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Peracidin® Gallon

by Angelini Pharma Inc.

Peracidin® Gallon (081894) is a Class II device made by Angelini Pharma Inc., cleared under FDA 510(k) K962959 on 5 Jun 1998 and listed in FDA GUDID since 22 Mar 2024 (UDI-DI 00898021000389), active as of 22 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 22 Oct 2026

Documents

510(k) K962959

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00898021000389 UDI-DI Date22 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK962959 Date5 Jun 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K962959 decided 5 Jun 1998 Active
  • FDA GUDID UDI-DI 00898021000389 listed 22 Mar 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K962959
  2. Listed FDA GUDID 00898021000389

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Peracidin®
Generic name
Organic peroxy acid device sterilant, single-use
Model / Ref / Catalog
Gallon, 081894
Primary DI / UDI-DI
00898021000389
510(k) Number
FDA product code
MED
GMDN term
Organic peroxy acid device sterilant, single-use
Device class
Class II
Regulation number
880.6885
GUDID distribution status
In Commercial Distribution

Related devices

Category: Organic peroxy acid device sterilant, single-use

Cleared under the same submission (K962959)

and 5 more cleared under K962959

Similar devices

Other devices filed under FDA product code MED (Sterilant, Medical Devices).

Other devices from Angelini Pharma Inc.

See all devices from Angelini Pharma Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)