FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106105719
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN32DRSP2
Catalog number
SEN32DRSP2
Device description
DENTAL RESTORATION PACK
Published
2023-01-19
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
50197106105717PackageGS13In Commercial Distribution
10197106105719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710610571750197106105717
1019710610571910197106105719

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
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
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