NA eZinject Catheter
by C R I FDA registration: United States GUDID
Product code LKF
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00852073002081 | Date11 Oct 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
-
- Terminated Z-1077-06
The uterine stop component was not included with the device.
Specification
- Trade Name
- Na
- Generic Name
- Salpingographic catheter
- Model / Ref / Catalog
- eZinject Catheter, VMI1162
- Primary DI / UDI-DI
- 00852073002081
- 510(k) Number
- FDA Product Code
- LKF
- GMDN Term
- Salpingographic catheter
- Device Class
- Class II
- Regulation Number
- 884.4530
- Commercial Distribution
- In Commercial Distribution
Other devices from C R I
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (1)
- FDA UDI 143b85ed-d54e-4e2b-ad09-dd3e2eaee48f