FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488167495
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-3502A
Catalog number
32-3502A
Device description
US IMAGE GUIDED BIOPSY
Published
2016-07-08
Public version status
Update
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
OIJBiopsy needle guide kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIJBiopsy Needle Guide KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488167495PackageGS120In Commercial Distribution
10887488167497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748816749550887488167495
1088748816749710887488167497

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956075359CARDINAL HEALTHCardinal Health 200, LLCOIJ2025-08-11
16975122553660mindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-07-25
16975122553684mindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-07-25
16975122553707mindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-07-25
50197106788552CARDINAL HEALTHCardinal Health 200, LLCOIJ2025-06-05
16971554726597InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16971554726870InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554726989MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727283MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727306MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727320MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727344MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122551096InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122551130InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122553004InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553014MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553021MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553038MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553045MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553649MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122553721InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122553745InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122558627InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
50198956069990CARDINAL HEALTHCardinal Health 200, LLCOIJ2025-05-07
00628055481225EV29L Non-Sterile Reusable PrecisionPoint AdapterExact Imaging IncOIJ2025-05-05
06971554721830InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554727825InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554727832InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554728006InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554728013InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01