Identity
- Trade Name
- ENT MR8 FDA UDI
- Generic Name
- Surgical power tool system control unit, pneumatic FDA UDI
- Device Name
- DRILL MOTOR 1847DRLMTR-R ENTMR8 OTO RFRB FDA UDI
- Model / Reference
- 1847DRLMTR-R FDA UDI
- Description
- DRILL MOTOR 1847DRLMTR-R ENTMR8 OTO RFRB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000357054 FDA UDI
- 510(k) Number
- K183515 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Surgical power tool system control unit, pneumatic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 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, pneumatic
Ent Mr8 by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system control unit, pneumatic.
- Integrated Power Console — MEDTRONIC XOMED, INC. · Class II
- Midas Rex® — MEDTRONIC XOMED, INC. · Class II
- MIDAS REX® — MEDTRONIC XOMED, INC. · Class II
- VISAO™ — MEDTRONIC XOMED, INC. · Class II
- Midas Rex® — MEDTRONIC XOMED, INC. · Class II
- Indigo — MEDTRONIC XOMED, INC. · Class II
- VISAO® — MEDTRONIC XOMED, INC. · Class II
- MPS® — MEDTRONIC XOMED, INC. · Class II
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 24e7256d-7b80-47c3-85ea-0ba2d934e180 35 fields · synced Jun 9, 2026