Identity
- Trade Name
- Midas Rex® FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- BLADE 110SB95-06F-BAY SO 11X10MM FN BAY FDA UDI
- Model / Reference
- 110SB95-06F-BAY FDA UDI
- Description
- BLADE 110SB95-06F-BAY SO 11X10MM FN BAY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169213241 FDA UDI
- 510(k) Number
- K081475 FDA UDI
- FDA Product Code
- HBE FDA UDIERL FDA UDI
- GMDN Term
- Orthopaedic bur, single-use 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, single-use
Midas Rex® by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bur, single-use.
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- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- ULTRAPOWER — Conmed Corporation · Class I
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Cleared under the same submission
K081475 also covers:
- Indigo — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- Indigo™ — MEDTRONIC XOMED, INC.
- MIDAS REX® — MEDTRONIC XOMED, INC.
- Midas Rex® — MEDTRONIC XOMED, INC.
- Midas Rex® — MEDTRONIC XOMED, INC.
- SKEETER® — MEDTRONIC XOMED, INC.
- Skeeter® — MEDTRONIC XOMED, INC.
- VISAO ™ — MEDTRONIC XOMED, INC.
- VISAO™ — MEDTRONIC XOMED, INC.
- MIDAS REX LEGEND — Medtronic Powered Surgical Solutions
- MIDAS REX MICROSAWS — 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 2856d6f5-bc60-4a34-b409-c8bad1436240 35 fields · synced Jun 9, 2026