FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488954820
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PECGDRCMU
Catalog number
PECGDRCMU
Device description
DENTAL RESTORATION EXTRACT
Published
2018-04-26
Public version status
Update
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
EBODenture repair kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBODenture Repair KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488954828PackageGS11In Commercial Distribution
10887488954820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748895482850887488954828
1088748895482010887488954820

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

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
00372494101915Repair-itDoc Brands, Inc.EBO2022-03-09
00852305002117PERK Emergency Denture Repair KitPERMA LABORATORIES LLCEBO2018-06-14
50887488954828CARDINAL HEALTHCardinal Health 200, LLCEBO2018-04-26
10887488844749CARDINAL HEALTHCardinal Health 200, LLCEBO2017-12-18
50887488844747CARDINAL HEALTHCardinal Health 200, LLCEBO2017-12-18
D8370640000Porcelain Etching PasteTaub ProductsEBO2016-12-05
D8370610000FUSION SilaneTaub ProductsEBO2016-10-26
D8370610020FUSION SilaneTaub ProductsEBO2016-10-26
D8370620000FUSION SilaneTaub ProductsEBO2016-10-26
D8370620010FUSION SilaneTaub ProductsEBO2016-10-26
D8370620100FUSION SilaneTaub ProductsEBO2016-10-26
D8370620110FUSION SilaneTaub ProductsEBO2016-10-26
D8370620200FUSION SilaneTaub ProductsEBO2016-10-26
00010705400913Repair-ItMAJESTIC DRUG CO. INC.EBO2016-07-27
20010705400917Repair-ItMAJESTIC DRUG CO. INC.EBO2016-07-27
10887488469638CARDINAL HEALTHCardinal Health 200, LLCEBO2016-07-01
50887488469636CARDINAL HEALTHCardinal Health 200, LLCEBO2016-07-01