FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106638040
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN7IABOUC
Catalog number
SAN7IABOUC
Device description
AUTOGUIDE BIOPSY PACK
Published
2024-06-11
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
50197106638048PackageGS11In Commercial Distribution
10197106638040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710663804850197106638048
1019710663804010197106638040

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
20885380214377KendallCB2LCB2L2026-10-12
20885380214384KendallCB2LITECB2LITE2026-10-12
20885380214391KendallCB2XLCB2XL2026-10-12
20885380214407KendallCB3LCB3L2026-10-12
20885380214414KendallCB4LCB4L2026-10-12
10192253046397Kendall55535PAMD55535PAMD2023-09-27
10192253046762Kendall55588BAMD55588BAMD2023-10-09
10885380173691Curity6309G6309G2019-11-14
20192253039358Kerlix458845882025-03-19
20192253039365Kerlix50425042-2025-03-19
20192253039372Kerlix61206120-2025-03-19
20192253039396Kerlix507250722025-03-19
20192253039594Kerlix258525852025-03-19
20885380173490Curity2556G2556G2019-11-14
20885380173513Curity2835G2835G2019-11-14
20192253008347CARDINAL HEALTH5005005005002020-09-24
20192253016632Kendall222002A222002A-2024-02-28
20192253016830Kendall30710001307100012024-02-28
20192253017813KendallEF00149EF001492024-02-28
20885380130950MEDI-VAC65652-11965652-1192018-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874549309CertAlignFastnAlign Holdings Inc.OIJ2026-09-21
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
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06945868603823SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
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06945868603847SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
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06945868605872SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
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06945868605896SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605902SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
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06945868605964SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
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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