FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106968192
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT73RUKSA
Catalog number
SOT73RUKSA
Device description
SDMC ROBOTIC UROLOGY 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
NWUEndoscope introducer kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106968190PackageGS12In Commercial Distribution
10197106968192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710696819050197106968190
1019710696819210197106968192

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, medicated, single-useA collection of various sterile ophthalmic surgical instruments, dressings, and the necessary materials which includes a pharmaceutical(s) intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). 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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956495067CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956502789CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956518056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956527232CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956528963CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956457768CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956465749CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956486065CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956491939CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956508286CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956512382CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956526686CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956527621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956528260CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956481435CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956500631CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956525061CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956526358CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06
10198956453791CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956503465CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956512399CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956517523CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-23
10198956364349CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956408739CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956428775CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956474673CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482272CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482562CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956489684CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956496309CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08