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Mepilex® Border Flex 595011

by Mölnlycke Health Care AB 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07333350030018 UDI-DI Date23 Oct 2025ListedStatusListed 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  • Withdrawn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
Mepilex® Border Flex
Generic Name
Wound-nonadherent dressing, absorbent, non-antimicrobial
Model / Reference
595011
Primary DI / UDI-DI
07333350030018
FDA Product Code
NAC
GMDN Term
Wound-nonadherent dressing, absorbent, non-antimicrobial
Device Class
Class I
Regulation Number
878.4018
GUDID distribution status
In Commercial Distribution

Other devices from Mölnlycke Health Care AB

See all devices from Mölnlycke Health Care AB →

Properties

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

Other properties (9)

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