FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106270974
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN32DRSP5
Catalog number
SEN32DRSP5
Device description
DENTAL RESTORATION PACK
Published
2023-05-11
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
50197106270972PackageGS13In Commercial Distribution
10197106270974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710627097250197106270972
1019710627097410197106270974

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

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
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