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ManaMed Air Customizable Short Large

by Manamed LLC

ManaMed Air Customizable Short Large (MACAIR01-S-L) is a Class I device made by Manamed LLC, listed in FDA GUDID since 28 Aug 2023 (UDI-DI 00810113682860), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810113682860 UDI-DI Date28 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ManaMed
Generic name
Cast boot
Model / Ref / Catalog
ManaMed Air Customizable Short Large, MACAIR01-S-L
Primary DI / UDI-DI
00810113682860
FDA product code
ITW
GMDN term
Cast boot
Device class
Class I
Regulation number
890.3475
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ITW (Joint, Ankle, External Brace).

Other devices from Manamed LLC

See all devices from Manamed LLC →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)