Midas Rex MR8 MR8-AA21DK
by Medtronic Powered Surgical Solutions EUDAMEDGUDID
Active
Ref MR8-AA21DK
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0763000B00013567X | Date21 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00763000440954 | Date23 Dec 2021 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Midas Rex MR8
- Generic Name
- Burring power tool attachment
- Device Name
- MR8 Angled Attachment
- Model / Reference
- MR8-AA21DK
- Primary DI / UDI-DI
- 00763000440954
- Basic UDI-DI
- 0763000B00013567X
- 510(k) Number
- FDA Product Code
- HBE
- EMDN Code
- Z12100985 Instruments for motorised neurosurgery systems - consumables
- GMDN Term
- Burring power tool attachment
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 882.4310
- Market of Registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Medtronic Powered Surgical Solutions
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No