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Spec Clean Pre Treatment Gel GEL12

by MicroCare, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberH816GEL121 UDI-DI Date23 Oct 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Spec Clean Pre Treatment Gel
Generic Name
Medical device cleaning agent
Model / Ref / Catalog
GEL12
Primary DI / UDI-DI
H816GEL121
FDA Product Code
FLG
GMDN Term
Medical device cleaning agent
Device Class
Class I
Regulation Number
880.6150
GUDID distribution status
In Commercial Distribution

Other devices from MicroCare, LLC

See all devices from MicroCare, LLC →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No