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Precept® 5558

by Precept Medical Products, Inc.

Precept 5558 is a patient gown (FDA Class I; FDA product code FME, Gown, Examination) made by Precept Medical Products, Inc., listed in FDA GUDID since 18 Sep 2018 (UDI-DI 20814707021473), 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 Number20814707021473 UDI-DI Date18 Sep 2018ListedStatusListed 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  • Withdrawn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
Precept®
Generic name
Patient gown, single-use
Model / reference
5558
Primary DI / UDI-DI
20814707021473
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 Precept Medical Products, Inc.

See all devices from Precept Medical Products, Inc. →

Properties

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