Home GUDID H362999162 Medegen Medical products
Primary DI H362999162
Brand Medegen Medical products
Company MEDEGEN MEDICAL PRODUCTS, LLC
Model 99916
Catalog number 99916
Device description Gown: Isol Blu Poly 75/Cs
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name OEA Non-Surgical Isolation Gown
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEA Non-Surgical Gown General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H362999162 Primary HIBCC 0 H362999160 Unit of Use HIBCC 0
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 055527753 Device count 75 Premarket exempt true Lot or batch true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00700812003892 Medegen Medical Products, LLC 2565 2020-12-20 H3621580 Medegen Medical products 158 158 2016-09-23 H362158TY0 Medegen Medical products 158TY 158TY 2016-09-23 H362158V0 Medegen Medical products 158V 158V 2016-09-23 H3621780 Medegen Medical products 178 178 2016-09-23 H362178TY0 Medegen Medical products 178TY 178TY 2016-09-23 H362178V0 Medegen Medical products 178V 178V 2016-09-23 H3621800 Medegen Medical products 180 180 2016-09-23 H362180S0 Medegen Medical products 180S 180S 2016-09-23 H362180TY0 Medegen Medical products 180TY 180TY 2016-09-23 H362180V0 Medegen Medical products 180V 180V 2016-09-23 H3621820 Medegen Medical products 182 182 2016-09-23 H362182S0 Medegen Medical products 182S 182S 2016-09-23 H362182TY0 Medegen Medical products 182TY 182TY 2016-09-23 H362182V0 Medegen Medical products 182V 182V 2016-09-23 H3621840 Medegen Medical products 184 184 2016-09-23 H362184CN0 Medegen Medical products CN184 CN184 2016-09-23 H362184R0 Medegen Medical products 184R 184R 2016-09-23 H362184S0 Medegen Medical products 184S 184S 2016-09-23 H362184TY0 Medegen Medical products 184TY 184TY 2016-09-23
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