FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106731208
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA29PPNS5
Catalog number
SMA29PPNS5
Device description
PREP PACK
Published
2024-08-05
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
OJWShave prep kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJWShave Prep KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106731206PackageGS125In Commercial Distribution
10197106731208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710673120650197106731206
1019710673120810197106731208

GMDN Terms#

Term, Definition table
TermDefinition
Surgical patient preparation kitA collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. 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
10198956323216CARDINAL HEALTHCardinal Health 200, LLCOJW2026-02-12
10198956251137CARDINAL HEALTHCardinal Health 200, LLCOJW2026-01-22
50198956251135CARDINAL HEALTHCardinal Health 200, LLCOJW2026-01-22
10198956223905CARDINAL HEALTHCardinal Health 200, LLCOJW2025-10-28
10197106861271CARDINAL HEALTHCardinal Health 200, LLCOJW2025-02-18
50197106861279CARDINAL HEALTHCardinal Health 200, LLCOJW2025-02-18
10197106823378CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-13
50197106823376CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-13
10197106816233CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-07
50197106816231CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-07
50197106731206CARDINAL HEALTHCardinal Health 200, LLCOJW2024-08-05
10197106552353CARDINAL HEALTHCardinal Health 200, LLCOJW2024-07-12
50197106552351CARDINAL HEALTHCardinal Health 200, LLCOJW2024-07-12
10197106662984CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-25
50197106662982CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-25
10197106704004CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-21
50197106704002CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-21
10197106441541CARDINAL HEALTHCardinal Health 200, LLCOJW2023-11-09
50197106441549CARDINAL HEALTHCardinal Health 200, LLCOJW2023-11-09
10195594775384CARDINAL HEALTHCardinal Health 200, LLCOJW2022-08-10
50195594775382CARDINAL HEALTHCardinal Health 200, LLCOJW2022-08-10
10195594450755CARDINAL HEALTHCardinal Health 200, LLCOJW2021-12-22
50195594450753CARDINAL HEALTHCardinal Health 200, LLCOJW2021-12-22
10195594432317CARDINAL HEALTHCardinal Health 200, LLCOJW2021-11-24
50195594432315CARDINAL HEALTHCardinal Health 200, LLCOJW2021-11-24
10195594159412CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-20
50195594159410CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-20
10195594291242CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-19
50195594291240CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-19
10195594132217CARDINAL HEALTHCardinal Health 200, LLCOJW2021-07-22