Biosens cartridges Standard Pink Clear 4112521

GUDID 07290110501716

box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diameter ; 73mm long ; each cartridge is filled with 18Gr of Biosens Standard Pink Clear Thermoplastic pellets.

PERFLEX LTD

Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic
Primary Device ID07290110501716
NIH Device Record Keyb80e3ba4-9257-4fc2-88fe-b9ccf1ebb685
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiosens cartridges Standard Pink Clear
Version Model Number25mm Diam. Medium 73mm long
Catalog Number4112521
Company DUNS532176000
Company NamePERFLEX LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110501716 [Primary]

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-16
Device Publish Date2022-11-08

On-Brand Devices [Biosens cartridges Standard Pink Clear]

07290110501716box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diamet
07290110501709box of 6 identical cartridges sealed in a vacuum bag ; cartridge dimensions : 25mm diameter ; 98
07290110501693box of 6 identical cartridges sealed in a vacuum bag ; cartridge dimensions : 25mm diameter ; 10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.