FDA.reportPublic FDA data

Non Woven Sponge 2x2 4 ply

Primary DI
00850014433246
Brand
Non Woven Sponge 2x2 4 ply
Company
DISTRIBUTION UNLIMITED, LLC
Model
1
Catalog number
DU1202
Device description
is a sterile sponge for wound dressing, prepping, and scrubbing.
Published
2020-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10850014433243PackageGS1200In Commercial Distribution
20850014433240PackageGS125In Commercial Distribution
00850014433246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001443324310850014433243
2085001443324020850014433240
00850014433246008500144332468500144332460850014433246

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, non-sterileA non-medicated, non-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, cellulose pulp) 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2Inch
Length2Inch

Regulatory Flags#

DUNS number
926603486
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014433253Syringe 3ml w/o Needle1DU25032020-08-06
00850014433260Syringe 5ml w/o Needle1DU25052020-08-06
00850014433284Syringe 10ml w/o Needle1DU25102020-08-06
00850014433642Universal Block Procedure Trays1DU36402020-08-19
00850014433161Grounding Pads1DU21002020-08-13
00850014433130"IV Extension Set 6"" "1DU22602020-08-19
00850014433222"Tourniquet 1""x18"""1DU22102020-08-06
00850014433215ETCO2 Nasal Cannula1DU10902020-08-13
00850014433505"Cohesive bandage 2""x5yds stretched"1DU35502020-08-06
10850014433137IV Extension Set 6" 1DU22602020-08-19
20850014433646Universal Block Procedure Trays1DU36402020-08-19
00850014433239Sterile Specimen Cup with Temp Strip1DU31002020-08-13
00850014433154Nasal Oxygen Cannula1DU10102020-08-13
10850014433168Grounding Pads1DU21002020-08-13
20850014433219ETCO2 Nasal Cannula1DU10902020-08-13
10850014433236Sterile Specimen Cup with Temp Strip1DU31002020-08-13
00850014433109Anesthesia Mask (Large) 1DU10782020-08-06
00850014433123Anesthesia Mask (Medium) 1DU10732020-08-06
00850014433178"Ice Compress 4""x7"""1DU17032020-08-06
00850014433291"3ml Syringe w/ 18g x 1"" Needle"1DU25232020-08-06

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