FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594764690
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195594764692CARDINAL 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