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Encompass 45790-012W

by Encompass Group, L.L.C.

Encompass 45790-012W is a patient gown (FDA Class I; FDA product code FME, Gown, Examination) made by Encompass Group, L.L.C., listed in FDA GUDID since 12 Aug 2022 (UDI-DI 10612899003108), 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 Number10612899003108 UDI-DI Date12 Aug 2022ListedStatusListed 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  • Withdrawn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
Encompass
Generic name
Patient gown, single-use
Model / reference
45790-012W
Description
PEDIATRIC GOWN, S, 100EA TS PED GOWN, 9-12 MO, WHITE, PET, 25/BG, 4 BG/CS NONWOVEN
Primary DI / UDI-DI
10612899003108
FDA product code
FME
GMDN term
Patient gown, single-use
Device class
Class I
Regulation number
880.6265
GUDID distribution status
In Commercial Distribution

Related devices

Category: Patient gown, single-use

Similar devices

Other devices filed under FDA product code FME (Gown, Examination).

Other devices from Encompass Group, L.L.C.

See all devices from Encompass Group, L.L.C. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)