FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488523989
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA21RKBIB
Catalog number
SBA21RKBIB
Device description
ROBOT KIDNEY
Published
2016-10-24
Public version status
Update
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488523987PackageGS12In Commercial Distribution
10887488523989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748852398750887488523987
1088748852398910887488523989

GMDN Terms#

Term, Definition table
TermDefinition
Nephroscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments, dressings, pharmaceuticals, and the necessary materials used to perform a nephroscopic surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29
10198956513310CARDINAL HEALTHSOP23SACACSOP23SACAC2026-10-29
10198956517240CARDINAL HEALTHSOP31KAOSXSOP31KAOSX2026-10-29
10198956521032CARDINAL HEALTHSENCGTACPCSENCGTACPC2026-10-29
10198956531932CARDINAL HEALTHSBA8CBPSPBSBA8CBPSPB2026-10-29
10198956533592CARDINAL HEALTHSAN42PMTMPSAN42PMTMP2026-10-29
10198956533653CARDINAL HEALTHSCV4AAAJHVSCV4AAAJHV2026-10-29
10198956534490CARDINAL HEALTHPU13CPAJEPU13CPAJE2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956253209CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956552302CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956555693CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956558168CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956584013CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956591127CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956598737CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956608481CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956608559CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956620346CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
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