FDA.reportPublic FDA data

ALL TERRAIN

Primary DI
10608503050088
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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 rollA sterile device in the form of a long strip of stretchable, non-woven material (e.g., rayon/polyester), 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933509465
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608503050005ALL TERRAIN6085030500052020-12-16
00608503050074ALL TERRAIN6085030500742020-12-16
00608503050012ALL TERRAIN6085030500122020-12-16
00608503050081ALL TERRAIN6085030500812020-12-16
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
10608503050095ALL TERRAIN6085030500982020-12-16

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Primary DI, Brand, Company table
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