FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439348804
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PU08CYGH15
Catalog number
PU08CYGH15
Device description
KIT,CYSTO,GRANT
Published
2019-01-24
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
50888439348802PackageGS11In Commercial Distribution
10888439348804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843934880250888439348802
1088843934880410888439348804

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.

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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956498037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956498600CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956499164CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956367630CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956379855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956431669CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956469976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956482036CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956485655CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956492837CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956496590CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956499454CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956482791CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-03
10198956332102CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956372610CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956388598CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956394643CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956397712CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956448278CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956464322CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956469020CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956475786CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01