FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106963821
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA18CPAM1
Catalog number
SMA18CPAM1
Device description
25457, CIRCUMCISION PACK
Published
2025-03-06
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
50197106963829PackageGS13In Commercial Distribution
10197106963821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710696382950197106963829
1019710696382110197106963821

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197106953488CARDINAL HEALTHCardinal Health 200, LLCOHG2025-06-05
10197106839775CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-27
10197106963036CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-02
10197106988534CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-11
10197106983300CARDINAL HEALTHCardinal Health 200, LLCOHG2025-03-21
10197106920909CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-21
10197106556177CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-18
10197106919798CARDINAL 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
10197106765364CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-04
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