3A MEDICAL

Primary DI
00850029191209
Brand
3A MEDICAL
Company
3A Medical Products Co.,Ltd
Model
21001
Device description
Standard Surgical gown, Size LARGE , SINGLE USE ONLY, LEVEL 2 AAMI PB70
Published
2021-03-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850029191209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029191209008500291912098500291912090850029191209

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544515279
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500291910013A MEDICALS30012021-03-09
008500291910253A MedicalS30032021-03-03
008500291910323A MedicalS30042021-03-03
008500291910493A MedicalS30052021-03-03
008500291912163A MEDICAL3AJS00012021-03-18
008500291912233A MEDICAL310012021-03-18
008500291912303A MEDICAL210012021-03-18
008500291910633A MEDICALS40022021-03-10
008500291910703A MEDICALS40032021-03-10
008500291910873A MEDICALS40042021-03-10
008500291910943A MEDICALS40052021-03-10
008500291911003A MEDICALS30012021-03-10
008500291911173A MEDICALS30022021-03-10
008500291911553A MEDICALS40012021-03-10
008500291911623A MEDICALS40022021-03-10
008500291911793A MEDICALS40032021-03-10
008500291911863A MEDICALS40042021-03-10
008500291911933A MEDICALS40052021-03-10
008500291910183A MEDICALS30022021-03-09
008500291910563A MEDICALS40012021-03-09