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Rexall 77-330

by Dolgencorp, LLC

Rexall 77-330 is a Class II device made by Dolgencorp, LLC, cleared under FDA 510(k) K032362 on 4 Dec 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00845717773300), 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) K032362

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 Number00845717773300 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK032362 Date4 Dec 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K032362 decided 4 Dec 2003 Active
  • FDA GUDID UDI-DI 00845717773300 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K032362
  2. Listed FDA GUDID 00845717773300

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rexall
Generic name
Infrared patient thermometer, skin
Model / Ref / Catalog
77-330
Primary DI / UDI-DI
00845717773300
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)