Identity
- Trade Name
- Ponto FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Insertion indicator FDA UDI
- Model / Reference
- M52366 FDA UDI
- Description
- Insertion indicator FDA UDI
Identifiers
- Catalog Number
- M52366 FDA UDI
- Primary DI / UDI-DI
- 05712149009909 FDA UDI
- FDA Product Code
- MAH FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ponto by Oticon Medical — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oticon Medical
Sources (1)
- FDA UDI a155fa3d-3a78-4dab-ada6-40738bd2f126 36 fields · synced May 30, 2026