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TECHStyles Gown Back 13-405N

by Techstyles

TECHStyles Gown Back 13-405N is a surgical gown (FDA Class II; FDA product code FYA, Gown, Surgical) made by Techstyles, listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00612899134058), 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 Number00612899134058 UDI-DI Date31 Aug 2016ListedStatusListed 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  • Withdrawn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
TECHStyles Gown Back
Generic name
Surgical gown, single-use
Model / reference
13-405N
Primary DI / UDI-DI
00612899134058
FDA product code
FYA
GMDN term
Surgical gown, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Surgical gown, single-use

Similar devices

Other devices filed under FDA product code FYA (GOWN, SURGICAL).

Other devices from Techstyles

Properties

  • Sterilise before use
  • Single use
  • Lot / batch number
Other properties (12, all answered No)