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ManaEZ Ankle 06 Large EZANKLE06L

by Manamed LLC

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 Number00810113682921 UDI-DI Date26 Sep 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  • Withdrawn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
ManaEZ Ankle 06 Large
Generic Name
Ankle/foot orthosis
Model / Ref / Catalog
EZANKLE06L
Primary DI / UDI-DI
00810113682921
FDA Product Code
ITW
GMDN Term
Ankle/foot orthosis
Device Class
Class I
Regulation Number
890.3475
GUDID distribution status
In Commercial Distribution

Other devices from Manamed LLC

See all devices from Manamed LLC →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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