FDA.reportPublic FDA data

Dukal

Primary DI
20665973004833
Brand
Dukal
Company
Dukal LLC
Model
545
Catalog number
545
Device description
"Fluff Bandage Roll 4.5"" x 147"" 6-Ply, Non-Sterile"
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
20665973004833PrimaryGS10
00665973004839Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2066597300483320665973004833
00665973004839006659730048396659730048390665973004839

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
100
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20665973026675Dukal60409604092022-12-06
00665973027456Dukal700710470071042022-12-06
10665973032631Dukal550055002026-01-12
10665973032648Dukal550155012026-01-12
10665973032655Dukal550255022026-01-12
10665973032662Dukal550355032026-01-12
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
10665973033027Dukal553055302026-02-26
20665973033024Dukal553055302026-02-26
10665973018154American White Cross7665033 and 76900007665033 and 76900002022-12-07
10665973018178American White Cross767503376750332022-12-06
00665973022611Dukal985198512022-12-06
10665973020911Dukal11130111302026-01-30
10665973020935Dukal11127111272026-01-30
20665973020918Dukal11130111302026-01-30
20665973020932Dukal11127111272026-01-30
10665973020737Dukal10533105332022-12-06

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