FDA.report

MediChoice

Primary DI
30885632070567
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GZBN2004
Device description
Gauze Bandage Roll Bulk Non-Sterile 6 Inch X 4.0 Yards X-Large 3-Ply 100% Cotton Single Use Only Not Made With Natural Rubber Latex MediChoice Non-Acute Only
Published
2020-09-16
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

Related Records

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30885632070567PackageGS18In Commercial Distribution
20885632070560PrimaryGS10
10885632070563Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088563207056730885632070567
2088563207056020885632070560
1088563207056310885632070563

GMDN Terms

TermDefinition
Woven gauze roll, non-sterileA non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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