FDA.reportPublic FDA data

ALL TERRAIN

Primary DI
10608503050071
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
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
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 pad, sterileA non-medicated sterile 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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Primary DI, Brand, Company table
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06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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