Identity
- Trade Name
- HCHC LAP CHOLE KIT FDA UDI
- Generic Name
- Ligation clip, metallic FDA UDI
- Device Name
- Kit Contains: C0957, 5x100MM SEP SYS 6/BX, CANNULA/SEAL, C0682, 12x100MM SEP SYS W/UNIV SEAL 6/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CA090, DIRECT DRIVE® LCA 3/BX FDA UDI
- Model / Reference
- K0312 FDA UDI
- Description
- Kit Contains: C0957, 5x100MM SEP SYS 6/BX, CANNULA/SEAL, C0682, 12x100MM SEP SYS W/UNIV SEAL 6/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CA090, DIRECT DRIVE® LCA 3/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30607915121243 FDA UDI
- FDA Product Code
- HET FDA UDIGCJ FDA UDIFZP FDA UDIMDM FDA UDI
- GMDN Term
- Ligation clip, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI876.1500 FDA UDI878.4300 FDA UDI878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ligation clip, metallicLaparoscopic access cannula, single-useSpring-loaded pneumoperitoneum needle, single-use
Hchc Lap Chole Kit by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 46f4c717-8a5c-4bc3-9106-e3e8da00e470 34 fields · synced Jun 6, 2026