FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106921364
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN7IABOU1
Catalog number
SAN7IABOU1
Device description
AUTOGUIDE BIOPSY PACK
Published
2025-01-23
Public version status
New
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
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
50197106921362PackageGS11In Commercial Distribution
10197106921364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710692136250197106921362
1019710692136410197106921364

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
06975122554851MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
06975122554868MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
06975122554875MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.OIJ2026-05-11
06945868600471SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603809SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603816SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603823SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603830SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603847SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603878SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605872SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605889SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605896SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605902SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605919SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605926SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605933SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605940SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605957SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605964SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605971SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605988SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605995SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606008SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606015SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606022SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606039SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606046SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606053SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09