Data / Medical devices / United States / Plasti-Products, Inc.
Plasti-Products, Inc.: FDA-registered device maker in Omaha, NE, United States, 2 510(k) clearances
Plasti-Products, Inc. is registered with the FDA (registration 1930034) in Omaha, NE, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 3, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1930034
- Address
- 9904 N 109th Ave, Omaha, NE, United States, 68142
- Owner or operator
- PLASTI-PRODUCTS, INC. (1930034)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 8, 2001
- Registered through
- 2026
- Brand names listed
- GRAD, HORZONTAL ENTRY SHARPS CONTAINER, Monoject Horizontal Entry Sharps Container, PAN II, PLASTI PAN, Plasti Grad, URI PAN, VERTICAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedpan | FOB | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 3, 1997 | K970398 | SHARPS CONTAINER | FMI | Substantially Equivalent | Custom Medical Plastics, Inc. | accessdata.fda.gov |
| July 3, 1997 | K970383 | SHARPS CONTAINER | FMI | Substantially Equivalent | Custom Medical Plastics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bedpan
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Container, Specimen, Non-Sterile
Updated July 3, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.