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Clear Advantage Spirit Hydrocolloid Adhesive Sheath 9363

by C. R. Bard, Inc.

Ref 9363

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0801741XRBTTLCC9A Basic UDI-DI 00801741071911UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00801741071911 UDI-DI Date22 Sep 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Clear Advantage SPIRIT EUDAMED
Clear Advantage Spirit Hydrocolloid Adhesive Sheath GUDID
Generic Name
Urinary incontinence penis sheath/port, single-use
Device Name
Male External Catheter
Model / Ref / Catalog
9363
Primary DI / UDI-DI
00801741071911
Basic UDI-DI
0801741XRBTTLCC9A
FDA Product Code
NNX
EMDN Code
U070201 Sheath catheter for the treatment of incontinence
GMDN Term
Urinary incontinence penis sheath/port, single-use
Device Class
Class I
Regulation Number
876.5250
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 36 Millimeter

Related devices

Category: Urinary incontinence penis sheath/port, single-use

Other devices from C. R. Bard, Inc.

See all devices from C. R. Bard, Inc. →

Properties

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

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No