Identity
- Trade Name
- Midas Rex Clearview FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- TOOL DC SD12MH30T LGD 12CM DIST 3.0 MH3F FDA UDI
- Model / Reference
- SD12MH30T FDA UDI
- Description
- TOOL DC SD12MH30T LGD 12CM DIST 3.0 MH3F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000892722 FDA UDI
- 510(k) Number
- K081277 FDA UDI
- FDA Product Code
- HBE FDA UDIERL FDA UDI
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 FDA UDI874.4250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Category: Orthopaedic bur, reusable
Midas Rex Clearview by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bur, reusable.
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Indigo™ — Medtronic Powered Surgical Solutions · Class II
Cleared under the same submission
K081277 also covers:
- IPC Visao® — MEDTRONIC XOMED, INC.
- IPC™ Visao® — MEDTRONIC XOMED, INC.
- Indigo — MEDTRONIC XOMED, INC.
- Indigo — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Integrated Power Console — MEDTRONIC XOMED, INC.
- Midas Rex Clearview — MEDTRONIC XOMED, INC.
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 4d75570e-72ee-4048-a01b-09929b782a57 35 fields · synced May 30, 2026