FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439361276
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
33-8809A
Catalog number
33-8809A
Device description
CHOLANGIOGRAM TRAY
Published
2019-03-08
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
NWTEndoscopic Cholangiogram Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWTEndoscopic Cholangiogram KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439361276PackageGS120In Commercial Distribution
10888439361278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843936127650888439361276
1088843936127810888439361278

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. 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.

Sterilization Methods#

Method table
Method

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191072205483ACSAMERICAN CONTRACT SYSTEMS, INC.NWT2023-09-27
10197106075272CARDINAL HEALTHCardinal Health 200, LLCNWT2023-01-19
10195594826734CARDINAL HEALTHCardinal Health 200, LLCNWT2022-09-15
10195594349271CARDINAL HEALTHCardinal Health 200, LLCNWT2021-09-15
50195594349279CARDINAL HEALTHCardinal Health 200, LLCNWT2021-09-15
10195594165420CARDINAL HEALTHCardinal Health 200, LLCNWT2021-09-02
50195594165428CARDINAL HEALTHCardinal Health 200, LLCNWT2021-09-02
00191072138408ACSAMERICAN CONTRACT SYSTEMS, INC.NWT2021-07-21
10195594148867CARDINAL HEALTHCardinal Health 200, LLCNWT2021-06-15
50195594148865CARDINAL HEALTHCardinal Health 200, LLCNWT2021-06-15
00191072106438ACSAMERICAN CONTRACT SYSTEMS, INC.NWT2020-04-06
10888439572599CARDINAL HEALTHCardinal Health 200, LLCNWT2019-08-21
50888439572597CARDINAL HEALTHCardinal Health 200, LLCNWT2019-08-21
10888439361278CARDINAL HEALTHCardinal Health 200, LLCNWT2019-03-08
10381780490135Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONNWT2018-09-14
10887488923673CARDINAL HEALTHCardinal Health 200, LLCNWT2018-04-17
50887488923671CARDINAL HEALTHCardinal Health 200, LLCNWT2018-04-17
10887488734392CARDINAL HEALTHCardinal Health 200, LLCNWT2017-06-30
50887488734390CARDINAL HEALTHCardinal Health 200, LLCNWT2017-06-30
08714729456797RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729748861RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729748878RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729748892RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729749097RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729749110RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729749134RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729749172RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729749196RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729749219RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24
08714729749257RX Cholangiogram KitBOSTON SCIENTIFIC CORPORATIONNWT2016-09-24