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Envelo Arm Wrap Max Medium Short Beige 3112-AMS or 22118

by Sigvaris, Inc.

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 Number00745129335151 UDI-DI Date22 Jul 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  • Withdrawn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

Trade Name
Envelo Arm Wrap Max Medium Short Beige
Generic Name
General-purpose medical foam padding, single-use
Model / Ref / Catalog
3112-AMS or 22118, 3112-AMS
Primary DI / UDI-DI
00745129335151
FDA Product Code
MDR
GMDN Term
General-purpose medical foam padding, single-use
Device Class
Class I
Regulation Number
880.5160
GUDID distribution status
In Commercial Distribution

Other devices from Sigvaris, Inc.

See all devices from Sigvaris, Inc. →

Properties

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

Other properties (10)

  • Sterile: No
  • 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