FDA.reportPublic FDA data

Dermacea

Primary DI
10885380173653
Brand
Dermacea
Company
Cardinal Health 200, LLC
Model
441103G
Catalog number
441103G
Device description
Gauze Fluff Roll
Published
2019-11-14
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
50885380173651PackageGS160In Commercial Distribution
10885380173653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017365150885380173651
1088538017365310885380173653

GMDN Terms#

Term, Definition table
TermDefinition
Cottonoid padA cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

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Primary DI, Brand, Company table
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00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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