N/A 43103
by Medtronic PS Medical United States GUDID
Product code JXG
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00763000028305 | Date19 Mar 2020 | StatusIn distribution |
Coverage
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
-
- Terminated Z-0397-2014
Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
Specification
- Trade Name
- N/A
- Generic Name
- Peritoneal/atrial cerebrospinal fluid catheter
- Model / Reference
- 43103
- Primary DI / UDI-DI
- 00763000028305
- 510(k) Number
- FDA Product Code
- JXG
- GMDN Term
- Peritoneal/atrial cerebrospinal fluid catheter
- Device Class
- Class II
- Regulation Number
- 882.5550
- Commercial Distribution
- In Commercial Distribution
Other devices from Medtronic PS Medical
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- 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
Sources (1)
- FDA UDI aa94945d-6a84-45c7-a195-d35e256cde4d