FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106983300
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA18CPAM2
Catalog number
SMA18CPAM2
Device description
25457, CIRCUMCISION PACK
Published
2025-03-21
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
50197106983308PackageGS13In Commercial Distribution
10197106983300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710698330850197106983308
1019710698330010197106983300

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197106988848CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-03
10197106990711CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-03
10197106990469CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-01
10197106963821CARDINAL HEALTHCardinal Health 200, LLCOHG2025-03-06
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
10198459245817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHG2025-02-02
10198459240317Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHG2025-01-19
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
10197106755952CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-09
10197106732694CARDINAL HEALTHCardinal Health 200, LLCOHG2024-09-06