STERiJECT™ Needle PRE-32013
by Tsk Laboratory International Japan KK
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04573545740886 | Date20 Aug 2026 | StatusListed |
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- Withdrawn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 — GUDID listing Listed
Specification
- Trade Name
- STERiJECT™ Needle
- Generic Name
- Hypodermic needle, single-use
- Model / Reference
- PRE-32013
- Primary DI / UDI-DI
- 04573545740886
- 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
Other devices from Tsk Laboratory International Japan KK
See all devices from Tsk Laboratory International Japan KK →
Properties
Other properties (8)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No