FDA.reportPublic FDA data

ALL TERRAIN

Primary DI
00608503050074
Brand
ALL TERRAIN
Company
ROSEMONT VENTURES, INC.
Model
608503050074
Device description
Gauze Pads, 2 in x 2 in (50 mm x 50 mm)
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
10608503050071PackageGS172In Commercial Distribution
00608503050074PrimaryGS10
60608503050076Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060850305007110608503050071
00608503050074006085030500746085030500740608503050074
6060850305007660608503050076

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Regulatory Flags#

DUNS number
933509465
Device count
10
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
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
10608503050088ALL TERRAIN6085030500812020-12-16
10608503050095ALL TERRAIN6085030500982020-12-16

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