FDA.reportPublic FDA data

Cardinal Health™ Surgical Incise Drape with CHG

Primary DI
00817138014973
Brand
Cardinal Health™ Surgical Incise Drape with CHG
Company
AVERY DENNISON CORPORATION
Model
30cm x 35 cm
Catalog number
9375
Device description
Surgical drape containing CHG antimicrobial
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817138014973PrimaryGS10
10817138014970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817138014973008171380149738171380149730817138014973
1081713801497010817138014970

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No direct sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008256364
Device count
40
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817138014980Cardinal Health™ Surgical Incise Drape with CHG60x 45 cm93772023-06-21
00817138014997Cardinal Health™ Surgical Incise Drape with CHG60x 85 cm93792023-06-21
10817138014987Cardinal Health™ Surgical Incise Drape with CHG60x 45 cm93772023-06-21
10817138014994Cardinal Health™ Surgical Incise Drape with CHG60x 85 cm93792023-06-21
00817138010500ReliaTect® Post-Op Dressing with CHG 0496-0567-762018-08-31
00817138010517ReliaTect® Post-Op Dressing with CHG 0496-0568-762018-08-31
10817138010507ReliaTect® Post-Op Dressing with CHG 0496-0567-762018-08-31
20817138010511ReliaTect® Post-Op Dressing with CHG 0496-0568-762018-08-31

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Primary DI, Brand, Company table
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08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
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10080196025893MEDLINEMEDLINE INDUSTRIES, INC.KKX2022-10-03
10080196496563Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
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