FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425260997
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA29CYLMI
Catalog number
SBA29CYLMI
Device description
STERILE CYSTO PACK
Published
2016-07-13
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
NWUKit, introducer, endoscope

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425260995PackageGS14In Commercial Distribution
10885425260997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542526099550885425260995
1088542526099710885425260997

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
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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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