FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106183878
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN32DRSP4
Catalog number
SEN32DRSP4
Device description
DENTAL RESTORATION PACK
Published
2023-03-10
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
OFWRestorative instrument and component tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFWRestorative Instrument And Component TrayDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106183876PackageGS13In Commercial Distribution
10197106183878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710618387650197106183876
1019710618387810197106183878

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.

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956432109CARDINAL HEALTHCardinal Health 200, LLCOFW2026-05-08
10198956325388CARDINAL HEALTHCardinal Health 200, LLCOFW2026-03-16
50198956325386CARDINAL HEALTHCardinal Health 200, LLCOFW2026-03-16
10197106847596CARDINAL HEALTHCardinal Health 200, LLCOFW2024-12-20
10197106505762CARDINAL HEALTHCardinal Health 200, LLCOFW2024-02-02
50197106505760CARDINAL HEALTHCardinal Health 200, LLCOFW2024-02-02
10197106372876CARDINAL HEALTHCardinal Health 200, LLCOFW2023-07-19
50197106372874CARDINAL HEALTHCardinal Health 200, LLCOFW2023-07-19
10197106323892CARDINAL HEALTHCardinal Health 200, LLCOFW2023-06-15
50197106323890CARDINAL HEALTHCardinal Health 200, LLCOFW2023-06-15
10197106270974CARDINAL HEALTHCardinal Health 200, LLCOFW2023-05-11
50197106270972CARDINAL HEALTHCardinal Health 200, LLCOFW2023-05-11
50197106183876CARDINAL HEALTHCardinal Health 200, LLCOFW2023-03-10
10197106149409CARDINAL HEALTHCardinal Health 200, LLCOFW2023-02-17
50197106149407CARDINAL HEALTHCardinal Health 200, LLCOFW2023-02-17
10197106105719CARDINAL HEALTHCardinal Health 200, LLCOFW2023-01-19
10194717115083Regard™ROI CPS, LLCOFW2022-03-21
20194717115080Regard™ROI CPS, LLCOFW2022-03-21
10194717110460Regard™ROI CPS, LLCOFW2021-05-03
20194717110467Regard™ROI CPS, LLCOFW2021-05-03
10888439973976CARDINAL HEALTHCardinal Health 200, LLCOFW2021-01-04
50888439973974CARDINAL HEALTHCardinal Health 200, LLCOFW2021-01-04
10887488722412CARDINAL HEALTHCardinal Health 200, LLCOFW2017-04-25
50887488722410CARDINAL HEALTHCardinal Health 200, LLCOFW2017-04-25