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CARE 38 Ultimate Ribbed

by Care Latex International Us Inc

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08809822510566 UDI-DI Date21 Apr 2025ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Care
Generic Name
Basic male condom, Hevea-latex
Model / Reference
38 Ultimate Ribbed
Primary DI / UDI-DI
08809822510566
510(k) Number
FDA Product Code
HIS
GMDN Term
Basic male condom, Hevea-latex
Device Class
Class II
Regulation Number
884.5300
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No