FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106229132
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
08-5878B
Catalog number
08-5878B
Device description
SOFT TISSUE I AND D TRAY
Published
2023-06-05
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
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106229130PackageGS125In Commercial Distribution
10197106229132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710622913050197106229130
1019710622913210197106229132

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956515215CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-06
10198956457898CARDINAL HEALTHCardinal Health 200, LLCOJV2026-06-01
10197106247334CARDINAL HEALTHCardinal Health 200, LLCOJV2023-08-18
10195594797751CARDINAL HEALTHCardinal Health 200, LLCOJV2023-08-02
10197106059609CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-19
10197106162712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-05
10197106244470CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-16
10197106245224CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-15
10197106163962CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-14
10197106221785CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106236727CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106170540CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-18
10197106188712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-11
10197106262597CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-03
10197106110263CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-02
10197106243039CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-01
10197106244432CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-28
10197106258484CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-28
10197106246665CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-27
10197106220146CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-21
10197106226667CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-20
10197106229484CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106234334CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106240816CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106154281CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106182659CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106056516CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106136508CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106196533CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106175644CARDINAL HEALTHCardinal Health 200, LLCOJV2023-03-29