FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594349271
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTCGCPPC2
Catalog number
SOTCGCPPC2
Device description
CHOLANGIOGRAM PACK
Published
2021-09-15
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
NWTEndoscopic Cholangiogram Kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594349279PackageGS18In Commercial Distribution
10195594349271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559434927950195594349279
1019559434927110195594349271

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 Temperature040 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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

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
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
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