FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956586628
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT33CYTMC
Catalog number
SOT33CYTMC
Device description
CYSTO PACK
Published
2026-10-06
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
50198956586626PackageGS15In Commercial Distribution
10198956586628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658662650198956586626
1019895658662810198956586628

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. 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 urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956362666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956486300CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956502703CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956539365CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956555563CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956567795CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956569317CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956578241CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956578593CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956582538CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956588530CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956593787CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956594753CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956597617CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956598232CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956598928CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956599444CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-06
10198956570733CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-30
10198956396906CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956552548CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568419CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568518CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956574564CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956590526CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956593824CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956594074CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956595903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956388239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956531697CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956568372CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25