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Halo US 1216-10034

by Medical Devices, Inc.

Halo US 1216-10034 is a Class I device made by Medical Devices, Inc., listed in FDA GUDID since 18 Dec 2025 (UDI-DI 00850010608549), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850010608549 UDI-DI Date18 Dec 2025ListedStatusListed 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  • Withdrawn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
Halo
Generic name
Wound hydrogel dressing, non-antimicrobial
Model / Ref / Catalog
US 1216-10034
Primary DI / UDI-DI
00850010608549
FDA product code
NAD
GMDN term
Wound hydrogel dressing, non-antimicrobial
Device class
Class I
Regulation number
878.4020
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NAD (Dressing, Wound, Occlusive).

Other devices from Medical Devices, Inc.

See all devices from Medical Devices, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)