FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594641436
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN31PAN10
Catalog number
SAN31PAN10
Device description
IR PARACENTESIS PACK
Published
2022-04-12
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
GCABiliary Catheter for stone removal that may also allow for irrigation and contrast injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594641434PackageGS16In Commercial Distribution
10195594641436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559464143450195594641434
1019559464143610195594641436

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

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Primary DI, Brand, Company table
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06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
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06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910757NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
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50195594641434CARDINAL HEALTHCardinal Health 200, LLCGCA2022-04-12
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00690103205114FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205121FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205138FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205119FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205126FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205133FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00816349011696TaxiLake Region MedicalGCA2018-11-27
04711182607548Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2017-08-15
00816349011436AnchorwireLake Region MedicalGCA2017-01-25