Identity
- Trade Name
- M-access® HEDSTROEM FILE FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- Endodontic Instrument FDA UDI
- Model / Reference
- A16MA03104012 FDA UDI
- Description
- Endodontic Instrument FDA UDI
Identifiers
- Catalog Number
- A16MA03104012 FDA UDI
- Primary DI / UDI-DI
- J003A16MA031040121 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Manual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
M-access® HEDSTROEM FILE by Maillefer Instruments Holding Sàrl — 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
- Maillefer Instruments Holding Sàrl
Sources (1)
- FDA UDI f7fef6e3-dcbc-4022-9f27-d6cdaa88bd81 36 fields · synced Jun 9, 2026