FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488923671
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTCGCPPCA
Catalog number
SOTCGCPPCA
Device description
CHOLANGIOGRAM PACK
Published
2018-04-17
Public version status
Update
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
50887488923671PackageGS18In Commercial Distribution
10887488923673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748892367150887488923671
1088748892367310887488923673

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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
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
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
50888439361276CARDINAL HEALTHCardinal Health 200, LLCNWT2019-03-08
10381780490135Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONNWT2018-09-14
10887488923673CARDINAL 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