Identity
- Trade Name
- Fomon Rasp FDA UDI
- Generic Name
- Nasal file/rasp FDA UDI
- Device Name
- Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #7/8 FDA UDI
- Model / Reference
- 345-287A FDA UDI
- Description
- Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #7/8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896113060 FDA UDI
- FDA Product Code
- KBA FDA UDI
- GMDN Term
- Nasal file/rasp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8.5 Inch FDA UDI
Category: Nasal file/rasp
Fomon Rasp by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal file/rasp.
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- Ambler Surgical — Ambler Surgical, LLC · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI ae1d1a32-3564-48cc-b570-6dba69bf6f28 35 fields · synced Jun 1, 2026