Identity
- Trade Name
- DR. MELARVIE'S LAP CHOLE PACK FDA UDI
- Generic Name
- Rigid endoscopic grasping forceps, single-use FDA UDI
- Device Name
- Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX C4119, 32CM GRASPER REPOS CART, 10/BX FDA UDI
- Model / Reference
- K2681 FDA UDI
- Description
- Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX C4119, 32CM GRASPER REPOS CART, 10/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30607915133970 FDA UDI
- FDA Product Code
- NWV FDA UDIGCJ FDA UDIFZP FDA UDIMDM FDA UDI
- GMDN Term
- Rigid endoscopic grasping forceps, single-use FDA UDI
Classification
- Device Class
- Class I 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ligation clip, metallicLaparoscopic access cannula, single-useTissue extraction bagRigid endoscopic grasping forceps, single-use
For healthcare professionals, the DR. MELARVIE'S LAP CHOLE PACK is a comprehensive and durable laparoscopic access kit designed to provide safe and effective surgical procedures. Its versatile design allows for multiple use cases, including laparoscopy, thoracoscopy, and minimally invasive surgery.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 106b305d-b6fe-424e-9626-0bb6c0c8fc6e 34 fields · synced Jul 2, 2026