Identity
- Trade Name
- MIDAS REX™ FDA UDI
- Generic Name
- Burring power tool attachment FDA UDI
- Device Name
- ATT ASMC LEGEND METAL CUTTER FDA UDI
- Model / Reference
- ASMC FDA UDI
- Description
- ATT ASMC LEGEND METAL CUTTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000084929 FDA UDI
- 510(k) Number
- K170312 FDA UDI
- FDA Product Code
- HBB FDA UDI
- GMDN Term
- Burring power tool attachment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4370 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Burring power tool attachment
Midas Rex™ by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170312 also covers:
- Midas Rex® — MEDTRONIC XOMED, INC.
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
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 Powered Surgical Solutions
Sources (1)
- FDA UDI b508548b-d9b4-4959-8540-001221c962cb 35 fields · synced Jun 9, 2026