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ImaJin AJ4Y85

by Coloplast A/S 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03600040988688 UDI-DI Date14 Nov 2022ListedStatusListed 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  • Withdrawn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
ImaJin
Generic Name
Urological surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
AJ4Y85
Primary DI / UDI-DI
03600040988688
FDA Product Code
FAD
GMDN Term
Urological surgical procedure kit, non-medicated, single-use
Device Class
Class II
Regulation Number
876.4620
GUDID distribution status
In Commercial Distribution
Size
Length — 28 Centimeter

Related devices

Category: Urological surgical procedure kit, non-medicated, single-use

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No