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ImaJin BCHS61

by Coloplast A/S

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 Number05701780340199 UDI-DI Date12 Apr 2024ListedStatusListed 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  • Withdrawn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
BCHS61
Primary DI / UDI-DI
05701780340199
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
MRI Safety
MR Safe
Size
Length — 16 Centimeter
Catheter Gauge — 6 French

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