STERiJECT TM PRE-30025
by Tsk Laboratory, Japan 2 variants
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04571225315676 | Date17 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK970370 | Date10 Apr 1997 | StatusActive |
Recalls
-
- Terminated Z-0694-2012
Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- STERiJECT TM
- Generic name
- Hypodermic needle, single-use
- Model / reference
- PRE-30025
- Primary DI / UDI-DI
- 04571225315676
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Hypodermic needle, single-use
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 25 MillimeterOuter Diameter — 0.3 Millimeter
Other devices from Tsk Laboratory, Japan
Properties
Other properties (9)
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Prescription use: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No