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SF-3PL Solofit AAMI III SMS Gown Poly Reinforced Large

by Operating Room Innovations, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 31 May 2026. What this means

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854150007002 UDI-DI Date2 Mar 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Surgical gown, single-use
Model / Ref / Catalog
SF-3PL
Primary DI / UDI-DI
00854150007002
FDA Product Code
FYA
GMDN Term
Surgical gown, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
Not in Commercial Distribution

Other devices from Operating Room Innovations, Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No