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Freedom Clear 505411

by Coloplast A/S

Listed FDA GUDID listing, not in commercial distribution

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 Number05708932588928 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: not 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  • Withdrawn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
Freedom Clear
Generic Name
Urinary incontinence penis sheath/port, single-use
Model / Ref / Catalog
505411
Primary DI / UDI-DI
05708932588928
FDA Product Code
NNX
GMDN Term
Urinary incontinence penis sheath/port, single-use
Device Class
Class I
Regulation Number
876.5250
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 23 Millimeter
Lumen/Inner Diameter — 0.9 Inch

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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