Home GUDID 20860008925743 Gredale USA-Made AAMI Level 3 Surgical Gown (Large)
Primary DI 20860008925743
Brand Gredale USA-Made AAMI Level 3 Surgical Gown (Large)
Company Gredale LLC
Model GRE3000-L
Device description Gredale USA-Made AAMI Level 3 Surgical Gown (Large)
Published 2022-08-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
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 20860008925743 Package GS1 10 In Commercial Distribution 10860008925746 Primary GS1 0 00860008925749 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20860008925743 20860008925743 10860008925746 10860008925746 00860008925749 00860008925749 860008925749 0860008925749
GMDN Terms# Term, Definition table Term Definition Isolation gown, single-use A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
Regulatory Flags# DUNS number 079303209 Device count 10 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 true 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 10860008925722 Gredale USA-Made AAMI Level 1 Isolation Gown (Large) GRE1000-L 2022-08-23 10860008925739 Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large) GRE1000-XL 2022-08-23 10860008925746 Gredale USA-Made AAMI Level 3 Surgical Gown (Large) GRE3000-L 2022-08-23 10860008925753 Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large) GRE3000-XL 2022-08-23 20860008925729 Gredale USA-Made AAMI Level 1 Isolation Gown (Large) GRE1000-L 2022-08-23 20860008925736 Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large) GRE1000-XL 2022-08-23 20860008925750 Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large) GRE3000-XL 2022-08-23 10860008925708 Gredale USA-Made AAMI Level 2 Isolation Gown (Large) GRE2000-L 2022-07-12 10860008925715 Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large) GRE2000-XL 2022-07-12 20860008925705 Gredale USA-Made AAMI Level 2 Isolation Gown (Large) GRE2000-L 2022-07-12 20860008925712 Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large) GRE2000-XL 2022-07-12
Other Devices Sharing Product Codes# 
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