Identity
- Trade Name
- HALL OSTEON FDA UDI
- Generic Name
- Surgical power tool system handpiece, sawing, pneumatic FDA UDI
- Device Name
- HALL OSTEON STRAIGHT HANDPIECE FDA UDI
- Model / Reference
- 5038-001 FDA UDI
- Description
- HALL OSTEON STRAIGHT HANDPIECE FDA UDI
Identifiers
- Catalog Number
- 00503800100 FDA UDI
- Primary DI / UDI-DI
- 10845854023204 FDA UDI
- 510(k) Number
- K833187 FDA UDI
- FDA Product Code
- GET FDA UDI
- GMDN Term
- Surgical power tool system handpiece, sawing, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- Not 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
Hall Osteon by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI 3c2f2f0e-c963-4d36-a7cb-e0397fd00179 37 fields · synced Jun 8, 2026