FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106720967
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN11DPJE1
Catalog number
SEN11DPJE1
Device description
DENTAL PACK
Published
2024-11-15
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
OFACardiovascular surgical instruments tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFACardiovascular Surgical Instruments TrayCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106720965PackageGS13In Commercial Distribution
10197106720967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710672096550197106720965
1019710672096710197106720967

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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
50197106720965CARDINAL HEALTHCardinal Health 200, LLCOFA2024-11-15
10197106636435CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
50197106636433CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
10197106457368CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
10809160413616Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
50197106457366CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
20809160413613Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
10197106458495CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
50197106458493CARDINAL HEALTHCardinal Health 200, LLCOFA2023-10-13
00851788001174On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001730On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001747On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-09
00851788001006On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.OFA2023-08-08
10197106140499CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
50197106140497CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
10195594468828CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
50195594468826CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
10809160360156Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
20809160360153Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
00749756714402DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
50749756714407DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
10195594135928CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
50195594135926CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
10809160284223Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
20809160284220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
00811870033568CUSTOM HEALTHCARE SYSTEMS, INC.Manus Medical, LLCOFA2019-07-29
20811870033562CUSTOM HEALTHCARE SYSTEMS, INC.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-07-29
00811870032264Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24
00811870032677Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24
00811870033377Custom Healthcare Systems, Inc.Manus Medical, LLCOFA2019-06-24