T-Crystal cartridges Amhari/Purple Pink 112512

GUDID 07290110500221

Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diameter ; 73mm long ; each cartridge is filled with 18Gr of T-Crystal Amhari/Purple Pink Thermoplastic pellets.

PERFLEX LTD

Dental appliance fabrication material, thermoplastic
Primary Device ID07290110500221
NIH Device Record Key094cf404-7c42-476c-992b-b48ad875e65d
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Crystal cartridges Amhari/Purple Pink
Version Model Number25mm Diam. Medium 73mm long
Catalog Number112512
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
GS107290110500221 [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 Amhari/Purple Pink]

07290110500290Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diamet
07290110500221Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diamet
07290110500214Box of 6 identical cartridges sealed in aluminum vacuum bag ; cartridge dimensions : 25mm diamet

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