1. ORDERING

Taewoong Medical Co.,Ltd products are widely exported thourgh exclusive distributors each country.

We currently have exclusive distributors over 60 countries, and our professional partners deliver comprehensive support for all our products and solutions.

You can find the global network on website, and please contact customer service if you need more information.

2. EXPIRATION

All Taewoong Medical Co.,Ltd products have an expiration date on the Package label to ensure product integrity and sterility. Please be aware that storage conditions may affect shelf life.

*Representative Products

▶ Niti-S™ Self-Expandable Metal Stent (Except SPAXUS™-2years): 3years
▶ Endoscopic RFA: 3years
▶ Optimos™ Endoscopic Accessory: 3years
▶ Uventa™ Urology stent: 3years

3. STORAGE

Taewoong Medical Co., Ltd products should be stored in a cool, dry, dark condition. Temperature limitation depends on product and you can find exact limitation of temperature on the package label. Please don’t expose direct sun light to avoid degrade some materials.

4. STERILIZATION

Taewoong Medical Co., Ltd products are sterilized with Ethylene Oxide.

Ethylene Oxide is compatible with a wide variety of manufacturing materials (E.O 20%, CO2 80%) and with sealed Tyvek® packaging.

Effectiveness sterilization of Products manufactured by Taewoong Medical Co.,Ltd is certified the 10-6 Sterility assurance level (SAL) in accordance with ANSI/AAMI/ISO 11135-1:2007 Annex B. half cycle approach method.

 

*Sterilization Process Flow

Preconditioning Air Removal Steam Injection E.O Injection Exposure Flushing Aeration

For Specific information about a sterilization, please refer to the Instruction of Use or contact TaeWoong Medical Co.,Ltd Customer Service.

 

*Reference

ISO 11135-1 [2007] Sterilization of health care products Ethylene oxide

Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11135 [2014] Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

5. MRI INFORMATION

Taewoong Medical Co.,Ltd products’ label indicates MRI Safety with international standards of safety signs. The icons are intended for use on items that may be brought into or near the MRI environment as well as in product labeling.

 

14. MRI

MR-Conditional: Niti-S™ Self-Expanble Metal Stent is determined to be MR-conditional. Non-Clinical testing demonstrated that the Niti-S™ Self-Expandable Metal Stent is MR Conditional according to ASTM F2503. A Patient with this device can be scanned safely, immediately after placement under specific conditions.

 

For Specific information about a MRI enviroment, please refer to the Instruction of Use or contact TaeWoong Medical Customer Service.

6. WARRANTY

Taewoong Medical Co., Ltd warrants that reasonable care has been applied within the design and subsequent manufacturing process of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond Taewoong Medical Co., Ltd’s control directly affect the instrument and the results obtained from its use.

Taewoong Medical Co., Ltd’s obligation under this warranty is limited to the replacement of this instrument and Taewoong shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this instrument.

Taewoong Medical Co., Ltd neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. Taewoong assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, expressed or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.

7. PRODUCT LABEL

1.european-community

Authorized representative in Europe
Représentant autorisé en Europe
Bevollmächtigter in Europa
Rappresentante autorizzato per l’Europa
Representante autorizado en Europa
Avrupa yetkili temsilcisi
Autoriseret repræsentant i Europa
유럽 대리인

 

2.temperature-limitation

Temperature limitation
Limites de température
Temperaturvorgaben
Intervallo termico
Límites de temperatura
Isı sınırlaması
Temperaturgrænser
보관 온도

 

3. consultant instruction for use

Consult instructions for use
Consulter les instructions d’utilisation
Gebrauchsanleitung beachten
Consultare le istruzioni per l’uso
Consulte las instrucciones de uso
Kullanım talimatlarına bakın
Konsultér brugsanvisning
사용자 지침 참조

 

4.manufacturer

Manufacturer
Fabricant
Hersteller
Produttore
Fabricante
Üretici
Fabrikant
제조사

 

5.reference-number

Catalogue No.
No de référence
Katalog-Nr.
N. di catalogo
N° de catálogo
Katalog No.
Referencenummer
형명

 

6.sterilized-using-ethylene-oxide

Sterilized using ethylene oxide
Stérilisé à l’aide d’oxyde d’éthylène
Mit Ethylenoxid sterilisiert
Sterilizzato con ossido di etilene
Esterilizado por óxido de etileno
Etilen oksit kullanılarak sterilize edilmiştir
Steriliseret med ethylenoxid
E.O Gas 멸균

 

7.attention

Attention, consult instructions for use
Attention, consulter les instructions d’utilisation
Achtung: Gebrauchsanleitung beachten
Attenzione, consultare le istruzioni per l’uso
Atención, consulte
las instrucciones de uso
Dikkat! Kullanım talimatlarına bakın.
Vær opmærksom, konsultér brugsanvisning
주의,사용상 지시 참조

 

8.expiration-date

Use by(Expiration Date)
À utiliser avant (date d’expiration)
Verwendbar bis (Verfallsdatum)
Utilizzare entro (data di scadenza)
Utilizar antes de
(fecha de vencimiento)
Son Kullanma Tarihi
Bruges før (udløbsdato)
유효기간

 

9.serial-number

Serial No.
No de série
Serien-Nr.
N. Seriale
N° de serie
Seri No.
Serienummer
일련번호

 

10. do not reuse

Do not reuse
Ne pas réutiliser
Nicht wiederverwenden
Non riutilizzare
No reutilizar
Yeniden kullanmayın
Må ikke genbruges
재사용 금지

 

11.date of manufacture

Date of Manufacture
Date de fabrication
Datum der Herstellung
Data di produzione
Fecha de fabricación
Üretim Tarihi
Fabrikationsdato
제조일자

 

12. Do not resterilize

Do not resterilize
Ne pas stériliser à nouveau
Nur einmal sterilisieren!
Non risterilizzare
No reesterilizar
Yeniden sterilize etmeyin
Må ikke resteriliseres
재멸균 금지

 

13.do not use if pakage is damaged

Do not use if package is damaged
Ne pas utiliser si l’emballage est abîmé
Nicht verwenden, wenn die Verpackung beschädigt ist!
Non utilizzare la confezione se danneggiata
No usar si el paquete está dañado.
Ambalaj hasar görmüşse tekrar kullanmayın
Må ikke bruges, hvis emballagen er beskadiget
포장이 파손된 경우 사용금지

 

14. MRI

MR Conditional
RM conditionnelle
Bedingte magnetische Resonanzsicherheit
RM compatibile
RM condicional
Koşullu MR
MR-betinget
MR 조건부 입증

 

15.LOT number

Lot Number
Code de lot
Chargennummer
il numero di lotto
número de lote
lot numarası
lotnummer
로트번호

 

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