Identity
- Trade Name
- MR8 Stealth-Midas FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- MOTOR PM800N-R MR8 PNEUM NAVIGATED RFRB FDA UDI
- Model / Reference
- PM800N-R FDA UDI
- Description
- MOTOR PM800N-R MR8 PNEUM NAVIGATED RFRB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000063979 FDA UDI
- 510(k) Number
- K183644 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical power tool system control unit, line-powered
MR8 Stealth-Midas by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183644 also covers:
- MR8 Stealth-Midas — Medtronic PS Medical
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions
- MIDAS REX STEALTH MIDAS MR8 — Medtronic Powered Surgical Solutions
- MIDAS REX STEALTH-MIDAS MR8 — Medtronic Powered Surgical Solutions
- Midas Rex MR8 — Medtronic Powered Surgical Solutions
- Midas Rex MR8 — Medtronic Powered Surgical Solutions
- Midas Rex MR8 — 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 PS Medical
Sources (1)
- FDA UDI f26151be-6995-42ae-9ed0-35e18f549aa3 35 fields · synced May 30, 2026