Identity
- Trade Name
- Monopolar Spatula FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Model / Reference
- 20-30-074-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017376165 FDA UDI
- 510(k) Number
- K222011 FDA UDI
- FDA Product Code
- GEI FDA UDIGCJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI876.1500 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
No
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
Yes
FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, single-use
Monopolar Spatula by Human Xtensions , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical electrode, monopolar, single-use.
- Bowel Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
- USA Elite — Gyrus Acmi, Inc. · Class II
- Dorsey Grasper Inner Shaft — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- 5mm x 10mm Foam Sleeves — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
- CleanCoat — Covidien LP · Class II
- Stainless Steel Cardiac 2 Finger Heart Retractor - Large — ORANGE SURGICAL INSTRUMENTS, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Human Xtensions , Ltd.
Sources (1)
- FDA UDI 0068ef26-b62f-4400-9b11-93e274a3bc3c 33 fields · synced Jun 1, 2026