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Plasti-Products 146008

by Plasti-Products, Inc.

Plasti-Products 146008 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 10797876146082), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K970398

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10797876146082 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970398 Date3 Jul 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970398 decided 3 Jul 1997 Active
  • FDA GUDID UDI-DI 10797876146082 listed 15 Apr 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K970398
  2. Listed FDA GUDID 10797876146082

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Plasti-Products
Generic name
Sharps container
Model / reference
146008
Primary DI / UDI-DI
10797876146082
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

Related devices

Category: Sharps container

Cleared under the same submission (K970398)

and 1 more cleared under K970398

Similar devices

Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).

Other devices from Plasti-Products, Inc.

See all devices from Plasti-Products, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)