T-Crystal cartridges Standard Pink 112504

GUDID 07290110500146

box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diameter ; 107mm long ; each cartridge filled with 31Gr of T-Crystal Standard Pink Thermoplastic pellets.

PERFLEX LTD

Dental appliance fabrication material, thermoplastic
Primary Device ID07290110500146
NIH Device Record Keya13ecc09-333d-4ba3-954c-49299fb5fe72
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Crystal cartridges Standard Pink
Version Model Number25mm Diam. XLarge 107mm long
Catalog Number112504
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
GS107290110500146 [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 Date2022-08-05
Device Publish Date2022-07-28

On-Brand Devices [T-Crystal cartridges Standard Pink]

07290110500276Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diamet
07290110500153Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diamet
07290110500146box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diamet

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