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ManaEZ Thumb Spica Left, Extra Large EZTS3809L-XL

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 Number00810113683188 UDI-DI Date17 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  • Withdrawn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
ManaEZ Thumb Spica Left, Extra Large
Generic Name
Wrist/hand/finger stable-position orthosis
Model / Ref / Catalog
EZTS3809L-XL
Primary DI / UDI-DI
00810113683188
FDA Product Code
ILH
GMDN Term
Wrist/hand/finger stable-position orthosis
Device Class
Class I
Regulation Number
890.3475
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Manamed LLC

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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