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Puracyn® Plus OTC 6043

by Innovacyn, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818582012881 UDI-DI Date17 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Puracyn® Plus OTC
Generic Name
Wound hydrogel dressing, antimicrobial
Model / Reference
6043
Primary DI / UDI-DI
00818582012881
510(k) Number
FDA Product Code
FRO
GMDN Term
Wound hydrogel dressing, antimicrobial
Device Class
U
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 90 Milliliter

Related devices

Cleared under the same submission (K150799)

Other devices from Innovacyn, Inc.

See all devices from Innovacyn, Inc. →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No