FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488469636
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PECGDRCMS
Catalog number
PECGDRCMS
Device description
KIT,DENTAL RESTORATION EXTRACT
Published
2016-07-01
Public version status
Update
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
EBOover the counter denture repair kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBODenture Repair KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488469636PackageGS11In Commercial Distribution
10887488469638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748846963650887488469636
1088748846963810887488469638

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

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
10887488954820CARDINAL HEALTHCardinal Health 200, LLCEBO2018-04-26
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