Plasti-Products 100434
Plasti-Products 100434 is a sharps container (FDA Class II; FDA product code FMI, Needle, Hypodermic, Single Lumen) made by Plasti-Products, Inc., cleared under FDA 510(k) K970398 on 3 Jul 1997 and listed in FDA GUDID since 15 Apr 2016 (UDI-DI 10797876104341), 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 | Number10797876104341 | Date15 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK970398 | Date3 Jul 1997 | StatusActive |
Official records
- AccessGUDID record 10797876104341
- FDA 510(k) database K970398
Across registries
- FDA 510(k) K970398 decided 3 Jul 1997 Active
- FDA GUDID UDI-DI 10797876104341 listed 15 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K970398
- Listed FDA GUDID 10797876104341
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Plasti-Products
- Generic name
- Sharps container
- Model / reference
- 100434
- Primary DI / UDI-DI
- 10797876104341
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Sharps container
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).
- FLEXPEN NEEDLE by NOVO NORDISK INC.
- TERUMO MICRO TAPERED PEN NEEDLE by Kofu Factory of Terumo Corp.
- ARROW IPN915667 9058 by TELEFLEX INCORPORATED
- ULTICARE DISPOSABLE PEN NEEDLES by ULTI MED, INC.
- INFUSION NEEDLE IIPN by Medi Tex, Inc.
- TERUFUSION BLOOD ADMIN. SET by Terumo America, Inc.
- SHARPS COLLECTION CONTAINER - SAF-T-SHELL by American Medical Mfg., Inc.
- BLOOD COLLECTING NEEDLE AND HOLDERS by Abco Dealers, Inc.
- STERILE INSULIN PEN NEEDLE by SHINA CORP.
- BD Vacutainer Eclipse UltraFill Blood Collection Needle by Becton, Dickinson and Company