FDA.reportPublic FDA data

ALL TERRAIN

Primary DI
00608503050081
Brand
ALL TERRAIN
Company
ROSEMONT VENTURES, INC.
Model
608503050081
Device description
Rolled Gauze, 1 roll, 3 in x 2.5 yds. (76 mm x 2.28 m) unstretched
Published
2020-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10608503050088PackageGS172In Commercial Distribution
00608503050081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060850305008810608503050088
00608503050081006085030500816085030500810608503050081

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze roll/sheetA device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, 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.

Regulatory Flags#

DUNS number
933509465
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608503050005ALL TERRAIN6085030500052020-12-16
00608503050074ALL TERRAIN6085030500742020-12-16
00608503050012ALL TERRAIN6085030500122020-12-16
00608503050098ALL TERRAIN6085030500982020-12-16
00608503050036ALL TERRAIN6085030500362020-12-16
00608503050043ALL TERRAIN6085030500432020-12-16
00608503050050ALL TERRAIN6085030500502020-12-16
00608503050067ALL TERRAIN6085030500672020-12-16
10608503050002ALL TERRAIN6085030500052020-12-16
10608503050019ALL TERRAIN6085030500122020-12-16
10608503050033ALL TERRAIN6085030500362020-12-16
10608503050040ALL TERRAIN6085030500432020-12-16
10608503050057ALL TERRAIN6085030500502020-12-16
10608503050064ALL TERRAIN6085030500672020-12-16
10608503050071ALL TERRAIN6085030500742020-12-16
10608503050088ALL TERRAIN6085030500812020-12-16
10608503050095ALL TERRAIN6085030500982020-12-16

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