FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956539174
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA4JRBCM5
Catalog number
SBA4JRBCM5
Device description
PK ROBOTIC HPB CM
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50198956539172PackageGS12In Commercial Distribution
10198956539174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653917250198956539172
1019895653917410198956539174

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10198956522596CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956535589CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956537644CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956552111CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956571679CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956573666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956530355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548206CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548213CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548435CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956549258CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956549562CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956550186CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956561168CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956563582CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956543973CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956548107CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956556409CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956558830CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956542211CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-17
10809160528358HALYARDAVID MEDICAL, INC.NWU2026-08-01
10198956441842CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956497740CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956501881CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956509511CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956519657CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956537132CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539891CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27