Cagenix BarZero

Primary DI
90860002441941
Brand
Cagenix BarZero
Company
CAGENIX, INC.
Model
1000-05
Device description
Milled denture teeth for dental restoration
Published
2020-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90860002441941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9086000244194190860002441941

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
901-763-3784ajschulter@cagenix.com

Regulatory Flags#

DUNS number
030868250
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90860002441903Cagenix AccuFrame1000-012020-07-16
90860002441910Cagenix AccuFrame IC1000-022020-07-16
90860002441927Cagenix AccuFrame 3601000-032020-07-16
90860002441934Cagenix AccuFrame Overdenture1000-042020-07-16

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