FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106765364
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA18CPAMA
Catalog number
SMA18CPAMA
Device description
25457, CIRCUMCISION PACK
Published
2024-12-04
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
OHGCircumcision tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHGCircumcision TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106765362PackageGS13In Commercial Distribution
10197106765364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710676536250197106765362
1019710676536410197106765364

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956532977CARDINAL HEALTHCardinal Health 200, LLCOHG2026-09-04
10198956561700CARDINAL HEALTHCardinal Health 200, LLCOHG2026-09-04
10198956549548CARDINAL HEALTHCardinal Health 200, LLCOHG2026-08-26
10198956550216CARDINAL HEALTHCardinal Health 200, LLCOHG2026-08-26
10198956530485CARDINAL HEALTHCardinal Health 200, LLCOHG2026-07-27
10198956258808CARDINAL HEALTHCardinal Health 200, LLCOHG2026-07-20
10198956509405CARDINAL HEALTHCardinal Health 200, LLCOHG2026-07-16
10198956487383CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-08
10198956460119CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-03
10198956460867CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-03
10198956463882CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-01
10197106867617CARDINAL HEALTHCardinal Health 200, LLCOHG2025-07-28
10197106839775CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-27
10197106556177CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-18
10197106881255CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-13
10197106824412CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-15
10197106846117CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-14
10197106864937CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-11
10197106829028CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-26
10197106807903CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-25
10197106803172CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106819746CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106780510CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-08
10197106791189CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-31
10197106795729CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-11
10197106739754CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-01
10197106661765CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-27
10197106755952CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-09
10197106732694CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-06
10197106745489CARDINAL HEALTHCardinal Health 200, LLCOHG2024-08-19