N/A 8228053
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00763000034092 | Date10 Jun 2019 | StatusListed |
Recalls
-
- Terminated Z-2343-2012
- Terminated Z-2342-2012
- Terminated Z-2344-2012
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic Name
- Nerve-locating system
- Model / Reference
- 8228053
- Primary DI / UDI-DI
- 00763000034092
- 510(k) Number
- FDA Product Code
- ETN, GWF
- GMDN Term
- Nerve-locating system
- Device Class
- Class II
- Regulation Number
- 874.1820, 882.1870
- GUDID distribution status
- In Commercial Distribution
Other devices from Medtronic Xomed, Inc.
Properties
Other properties (10)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No