Identity
- Trade Name
- FeatherTouch® FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- CONVERTER 1922005 FEATHERTOUCH AUTO RASP FDA UDI
- Model / Reference
- 1922005 FDA UDI
- Description
- CONVERTER 1922005 FEATHERTOUCH AUTO RASP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681490051088 FDA UDI
- 510(k) Number
- K983025 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
FeatherTouch® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K983025 also covers:
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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI fc8aac16-2ea4-41d7-bf70-5bc172b5b992 36 fields · synced Jun 1, 2026