Identity
- Trade Name
- Applier, hemostatic clip FDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Model / Reference
- PR128-EB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661522041291 FDA UDI
- FDA Product Code
- HBT FDA UDI
- GMDN Term
- Open-surgery ligation clip applier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Open-surgery ligation clip applier
Applier, hemostatic clip by Peters Surgical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery ligation clip applier.
- WECK — TELEFLEX INCORPORATED · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- WECK — TELEFLEX INCORPORATED · Class I
- WECK — TELEFLEX INCORPORATED · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
- Vitalitec Clip Appliers — VITALITEC INTERNATIONAL, INC. · Class I
- WECK — TELEFLEX INCORPORATED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Peters Surgical
Sources (1)
- FDA UDI 22093a72-8ff9-46b1-8d23-27d186a1270c 32 fields · synced Jun 1, 2026