FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106720965
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
OTC
false
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

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
50197106636433CARDINAL HEALTHCardinal Health 200, LLCOFA2024-05-16
50197106457366CARDINAL HEALTHCardinal Health 200, LLCOFA2023-12-06
20809160413613Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2023-12-06
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
50197106140497CARDINAL HEALTHCardinal Health 200, LLCOFA2023-02-16
50195594468826CARDINAL HEALTHCardinal Health 200, LLCOFA2022-02-15
20809160360153Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2021-09-27
50749756714407DeRoyalDEROYAL INDUSTRIES, INC.OFA2021-06-23
50195594135926CARDINAL HEALTHCardinal Health 200, LLCOFA2021-06-10
20809160284220Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFA2020-05-28
20811870033562CUSTOM HEALTHCARE SYSTEMS, INC.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-07-29
20811870032268Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870032671Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870033371Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870033401Custom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-06-24
20811870032091Custom Healthcare Systems Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-01-23
20811870032107Custom Healthcare Systems Inc.CUSTOM HEALTHCARE SYSTEMS, INC.OFA2019-01-23
24026704522983PILLINGTELEFLEX INCORPORATEDOFA2018-09-15
10885403206474V. MuellerCAREFUSION 2200, INCOFA2018-08-17
10885403206481V. MuellerCAREFUSION 2200, INCOFA2018-08-17
50888439071144CARDINAL HEALTHCardinal Health 200, LLCOFA2018-08-03
10885403426384V. MuellerCAREFUSION 2200, INCOFA2018-01-16
10885403426421V. MuellerCAREFUSION 2200, INCOFA2018-01-16
10885403426216V. MuellerSTERIS CORPORATIONOFA2017-12-28
10885403426322V. MuellerSTERIS CORPORATIONOFA2017-12-28
10885403426353V. MuellerSTERIS CORPORATIONOFA2017-12-28