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One-Care

by MediVena, LLC 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 Number00810008212349 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Skin staple remover, single-use
Model / Ref / Catalog
5018 ONE-CARE Access Holder with Male Luer Adapter and Back-End Needle, 5018
Primary DI / UDI-DI
00810008212349
FDA Product Code
KST
GMDN Term
Skin staple remover, single-use
Device Class
Class I
Regulation Number
864.9125
GUDID distribution status
In Commercial Distribution

Other devices from MediVena, LLC

See all devices from MediVena, LLC →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No