Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- PENCIL/HANDPIECE, F/22-900/950 FDA UDI
- Model / Reference
- 22-A901 FDA UDI
- Description
- PENCIL/HANDPIECE, F/22-900/950 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479213064 FDA UDI
- 510(k) Number
- K000961 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrosurgical handpiece, single-use
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K000961 also covers:
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Bovie — BOVIE MEDICAL CORPORATION
- Argent — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- FOOT SWITCH — SONTEC INSTRUMENTS, INC.
- FORCEPS CORD — SONTEC INSTRUMENTS, INC.
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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI b0fabc30-3891-4961-94c4-a7eaa564f114 34 fields · synced Jun 6, 2026