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
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
06959664900093NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664900208NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901137NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901441NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664901458NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902578NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902653NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664902660NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903247NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903254NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664903261NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664907528NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910689NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910696NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910726NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664910733NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911006NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911013NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911082NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06959664911099NAHangzhou AGS MedTech Co., Ltd.GCA2026-07-17
06970057571027Stone Extraction BalloonJiangsu Vedkang Medical Science and Technology Co.,Ltd.GCA2026-04-14
06948318963102AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
06948318963119AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
04711182608309Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
04711182608316Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608306Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608313Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910719NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09