Identity
- Trade Name
- HEM-O-LOK LARGE ENDOSCOPIC APPLIER 10 MILIMETER, 45 CENTIMETER EUDAMEDWECK FDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Device Name
- Weck® Hem-o-lok® Endoscopic Clip Appliers, various EUDAMEDHEM-O-LOK LARGE ENDOSCOPIC APPLIER 10 MILIMETER, 45 CENTIMETER FDA UDI
- Model / Reference
- 544995L EUDAMEDIPN921710 FDA UDI
- Description
- HEM-O-LOK LARGE ENDOSCOPIC APPLIER 10 MILIMETER, 45 CENTIMETER FDA UDI
Identifiers
- Catalog Number
- 544995L FDA UDI
- Primary DI / UDI-DI
- 14026704727572 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000012JX EUDAMED
- Direct Marketing DI
- 44026704727573 EUDAMED
- FDA Product Code
- GDO FDA UDI
- EMDN Code
- L020802 MULTIPLE APPLICATORS OF CLIPS FOR VIDEO SURGERY, REUSABLE EUDAMED
- GMDN Term
- Open-surgery ligation clip applier FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Centimeter FDA UDI
Category: Open-surgery ligation clip applier
Weck by Teleflex Incorporated — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery ligation clip applier.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- Vitalitec Clip Appliers — VITALITEC INTERNATIONAL, INC. · Class I
- S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- Vitalitec Clip Appliers — VITALITEC INTERNATIONAL, INC. · Class I
- Griff für Titan Clipanlegezange ML V mit Sperre — GETSCH+HILLER Medizintechnik GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI 3ef0e7bf-1f33-4441-977f-696b74943f47 36 fields · synced Jul 16, 2026
- EUDAMED cea3f5c1-f166-456d-8da9-ebe148607148 61 fields · synced Jul 16, 2026