FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488734392
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN57AAOHH
Catalog number
SAN57AAOHH
Device description
STERILE CHOLEANGIOGRAM ADDS PK
Published
2017-06-30
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
50887488734390PackageGS15In Commercial Distribution
10887488734392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748873439050887488734390
1088748873439210887488734392

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

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
50887488923671CARDINAL HEALTHCardinal Health 200, LLCNWT2018-04-17
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