Biosens cartridges Standard Pink 4112504

GUDID 07290110501549

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

PERFLEX LTD

Dental appliance fabrication material, thermoplastic
Primary Device ID07290110501549
NIH Device Record Key8578889d-4401-4380-ac11-1705a513371d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiosens cartridges Standard Pink
Version Model Number25mm Diam. Extra Large 107mm long
Catalog Number4112504
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
GS107290110501549 [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

Devices Manufactured by PERFLEX LTD

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07290110501389 - Perflex Biosens2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Light Pink 200gr. net filled in jar and packed in box
07290110501433 - Perflex Biosens2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Purple Pink 1kg net filled in jar and packed in box
07290110501440 - Perflex Biosens2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Purple Pink 200gr. net filled in jar and packed in box
07290110501457 - Perflex Biosens2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Opaque Pink 1kg net filled in jar and packed in box
07290110501464 - Perflex Biosens2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Opaque Pink 200gr. net filled in jar and packed in box
07290110501471 - Perflex Biosens2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Light Pink Clear 1kg net filled in jar and packed in box
07290110501488 - Perflex Biosens2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Light Pink Clear 200gr. net filled in jar and packed in bo

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