FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380066580
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCL812
Catalog number
SCL812
Device description
Silicone Contact Layer8 x 12in. Dressing
Published
2019-05-30
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
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888499001322PackageGS15In Commercial Distribution
10888499001329PackageGS15In Commercial Distribution
10885380066580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888499001322008884990013228884990013220888499001322
1088849900132910888499001329
1088538006658010885380066580

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, non-antimicrobialA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent); it does not include an antimicrobial agent(s). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

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04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
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05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
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00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22