FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106505760
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN32DRSPC
Catalog number
SEN32DRSPC
Device description
DENTAL RESTORATION PACK
Published
2024-02-02
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
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
50197106505760PackageGS13In Commercial Distribution
10197106505762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710650576050197106505760
1019710650576210197106505762

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.

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
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
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
10197106183878CARDINAL HEALTHCardinal Health 200, LLCOFW2023-03-10
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