FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594764692
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
06-7800A
Catalog number
06-7800A
Device description
STAPLE REMOVAL PACK
Published
2022-08-12
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
MCATape, surgical, internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCATape, Surgical, InternalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594764690PackageGS120In Commercial Distribution
10195594764692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559476469050195594764690
1019559476469210195594764692

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50195594764690CARDINAL HEALTHCardinal Health 200, LLCMCA2022-08-12
34026704633174DEKNATELTELEFLEX INCORPORATEDMCA2019-09-05
34026704634003DEKNATELTELEFLEX INCORPORATEDMCA2019-09-04
14026704558947DEKNATELTELEFLEX INCORPORATEDMCA2019-01-14
34026704558941DEKNATELTELEFLEX INCORPORATEDMCA2019-01-14
34026704426363DEKNATELTELEFLEX INCORPORATEDMCA2017-12-12
34026704427445DEKNATELTELEFLEX INCORPORATEDMCA2017-08-15
34026704427452DEKNATELTELEFLEX INCORPORATEDMCA2017-08-15
04026704427161DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
04026704427444DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
04026704427451DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427165DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427448DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
24026704427455DEKNATELTELEFLEX INCORPORATEDMCA2017-05-10
34026704421962DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
34026704426264DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
34026704427254DEKNATELTELEFLEX INCORPORATEDMCA2017-04-19
24026704426151DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704426267DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704427257DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704427462DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421794DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421800DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421817DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704421961DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704422005DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
04026704558940DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421798DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421804DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16
24026704421811DEKNATELTELEFLEX INCORPORATEDMCA2015-10-16