Identity
- Trade Name
- MR8 Tools FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- TOOL MR8-10MH30SH 10CM MATCH 3MM SHORT FDA UDI
- Model / Reference
- MR8-10MH30SH FDA UDI
- Description
- TOOL MR8-10MH30SH 10CM MATCH 3MM SHORT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000447298 FDA UDI
- 510(k) Number
- K183515 FDA UDI
- FDA Product Code
- HBC FDA UDIHBB FDA UDIERL FDA UDIHXZ FDA UDIHBE FDA UDI
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4360 FDA UDI882.4370 FDA UDI874.4250 FDA UDI888.4540 FDA UDI882.4310 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
MR8 Tools 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
K183515 also covers:
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- ENT MR8 — Medtronic Powered Surgical Solutions
- MIDAS REX — Medtronic Powered Surgical Solutions
- MIDAS REX MR8 — 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 e7b8a45c-02d8-4765-809c-f1d5b2d06111 35 fields · synced Jun 9, 2026