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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106720967CARDINAL 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