Identity
- Trade Name
- STE. GENEVIEVE LAP CHOLE KIT FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX FDA UDI
- Model / Reference
- K0762 FDA UDI
- Description
- Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30607915125784 FDA UDI
- FDA Product Code
- GCJ FDA UDIFZP FDA UDIMDM FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
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-useEndoscopic electrosurgical handpiece/electrode, monopolar, single-use
Ste. Genevieve Lap Chole Kit by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
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- Single Use Electrosurgical Knife KD-655 — Olympus Medical Systems Corporation · Class II
- Polyp Pak — US Endoscopy · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
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 5a8264b4-d73f-462b-807f-c49d8df0185f 34 fields · synced May 29, 2026