Home GUDID 00850015378843 Stradis Healthcare
Primary DI 00850015378843
Brand Stradis Healthcare
Company EXACT MEDICAL MANUFACTURING, INC.
Model SH35
Catalog number SH35
Device description Extra Large Surgical Gown, AAMI 3, Non-reinf , Set-in Sleeve
Published 2020-07-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name FYA Gown, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FYA Gown, Surgical General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850015378843 Package GS1 768 In Commercial Distribution 00850015378836 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850015378843 00850015378843 850015378843 0850015378843 00850015378836 00850015378836 850015378836 0850015378836
GMDN Terms# Term, Definition table Term Definition Surgical gown, single-use A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
Regulatory Flags# DUNS number 014464314 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 06975424199361 Exact Medical Manufacturing, Inc. DEF5941 DEF5941 2026-05-20 06975424199378 Exact Medical Manufacturing, Inc. DEF5942 DEF5942 2026-05-20 06975424199385 Exact Medical Manufacturing, Inc. DEF5943 DEF5943 2026-05-20 06975424199392 Exact Medical Manufacturing, Inc. DEF5944 DEF5944 2026-05-20 06975424199408 Exact Medical Manufacturing, Inc. DEF5945 DEF5945 2026-05-20 06975424199415 Exact Medical Manufacturing, Inc. DEF5946 DEF5946 2026-05-20 06975424199422 Exact Medical Manufacturing, Inc. DEF5947 DEF5947 2026-05-20 06975424199354 Exact Medical Manufacturing, Inc. DEF5940 DEF5940 2026-05-19 06975424199750 Exact Medical Manufacturing, Inc. EN-RF-002 EN-RF-002 2026-05-19 06975424198722 Proficient Surgical PS2037 2026-03-11 06975424198739 Proficient Surgical PS8946 2026-03-11 16975424198729 Proficient Surgical PS2037 2026-03-11 16975424198736 Proficient Surgical PS8946 2026-03-11 06975424198838 Exact Medical Manufacturing, Inc. VPS-G4SC-S1 VPS-G4SC-S1 2026-03-09 06975424199279 Exact Medical Manufacturing, Inc. E6997 E6997 2026-03-09 26975424198832 Exact Medical Manufacturing, Inc. VPS-G4SC-S1 VPS-G4SC-S1 2026-03-09 16975424199276 Exact Medical Manufacturing, Inc. E6997 E6997 2026-03-09 06975424198449 Exact Medical Manufacturing, Inc. TMPH-2000 TMPH-2000 2025-11-19 06975424198456 Exact Medical Manufacturing, Inc. TMPH-2002 TMPH-2002 2025-11-19 06975424198463 Exact Medical Manufacturing, Inc. PS-6000 PS-6000 2025-11-19
Other Devices Sharing Product Codes#