Identity
- Trade Name
- MIDAS REX LEGEND FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- TOOL DS1TD24 LGND DPTH STP TST DRL 2.4MM FDA UDI
- Model / Reference
- DS1TD24 FDA UDI
- Description
- TOOL DS1TD24 LGND DPTH STP TST DRL 2.4MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000462949 FDA UDI
- 510(k) Number
- K191597 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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 Legend 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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Cleared under the same submission
K191597 also covers:
- Autoguide — MEDTRONIC NAVIGATION, INC.
- Autoguide — MEDTRONIC NAVIGATION, INC.
- Autoguide — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, 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 Powered Surgical Solutions
Sources (1)
- FDA UDI 52530b5a-59c4-46c9-abec-1f3cf3a81096 35 fields · synced Jun 9, 2026