Identity
- Trade Name
- HEM-O-LOK APPLIER LARGE 8" CURVED EUDAMEDWECK FDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Device Name
- Weck® Hem-o-lok® Ligating Clip Appliers, various s EUDAMEDHEM-O-LOK APPLIER LARGE 8" CURVED FDA UDI
- Model / Reference
- 544180 EUDAMEDIPN921597 FDA UDI
- Description
- HEM-O-LOK APPLIER LARGE 8" CURVED FDA UDI
Identifiers
- Catalog Number
- 544180 FDA UDI
- Primary DI / UDI-DI
- 14026704727428 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000010JT EUDAMED
- Direct Marketing DI
- 44026704727429 EUDAMED
- FDA Product Code
- GDO FDA UDI
- EMDN Code
- L020801 MULTIPLE CLIPS APPLICATORS FOR OPEN 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 — 8 Inch 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
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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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI d2b1c267-456e-499a-8e5d-76011eaeeef1 36 fields · synced Jul 28, 2026
- EUDAMED 6d1d4d7c-64bd-4367-8bd7-9e5a4b7f20b4 61 fields · synced Jul 28, 2026