FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488844749
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PECGDRCMT
Catalog number
PECGDRCMT
Device description
KIT,DENTAL RESTORATION EXTRACT
Published
2017-12-18
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
50887488844747PackageGS11In Commercial Distribution
10887488844749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748884474750887488844747
1088748884474910887488844749

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
10884521022683Monoject85121851212016-09-24
10884521023437Monoject890689062019-07-19
30884521018444Monoject8990Y8990Y2017-01-06
40884521018298Monoject89671896712016-09-24
40884521018380Monoject8970Y8970Y2017-01-06
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

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
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