FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594165428
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN57AAOHI
Catalog number
SAN57AAOHI
Device description
CHOLEANGIOGRAM ADDS PACK
Published
2021-09-02
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
50195594165428PackageGS15In Commercial Distribution
10195594165420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559416542850195594165428
1019559416542010195594165420

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
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
10195594349271CARDINAL HEALTHCardinal Health 200, LLCNWT2021-09-15
50195594349279CARDINAL HEALTHCardinal Health 200, LLCNWT2021-09-15
10195594165420CARDINAL 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