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ProView Plus PM3554

by MicroCare, LLC

ProView Plus PM3554 (PM3554-1) is a Class II device made by MicroCare, LLC, cleared under FDA 510(k) K953829 on 9 Nov 1995 and listed in FDA GUDID since 26 Oct 2022 (UDI-DI H816MPM35541), 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) K953829

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 NumberH816MPM35541 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK953829 Date9 Nov 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K953829 decided 9 Nov 1995 Active
  • FDA GUDID UDI-DI H816MPM35541 listed 26 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K953829
  2. Listed FDA GUDID H816MPM35541

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProView Plus
Generic name
Sterilization packaging, single-use
Model / Ref / Catalog
PM3554, PM3554-1
Primary DI / UDI-DI
H816MPM35541
FDA product code
KCT
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K953829)

and 8 more cleared under K953829

Similar devices

Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Other devices from MicroCare, LLC

See all devices from MicroCare, LLC →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)