VanishPoint® 10134
by Retractable Technologies, Inc.
VanishPoint® 10134 is a Class II device made by Retractable Technologies, Inc., cleared under FDA 510(k) K980069 on 12 Feb 1998 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00613703101334), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00613703101334 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK980069 | Date12 Feb 1998 | StatusActive |
Official records
- AccessGUDID record 00613703101334
- FDA 510(k) database K980069
Across registries
- FDA 510(k) K980069 decided 12 Feb 1998 Active
- FDA GUDID UDI-DI 00613703101334 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K980069
- Listed FDA GUDID 00613703101334
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VanishPoint®
- Generic name
- Metered-delivery hypodermic syringe/needle
- Model / Ref / Catalog
- 10134
- Primary DI / UDI-DI
- 00613703101334
- 510(k) Number
- FDA product code
- MEG
- GMDN term
- Metered-delivery hypodermic syringe/needle
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
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