PERFLEX LTD

Address:7 Giborey Israel St. Beit Adar entry D 1,Netanya Central,IL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Resin, Denture, Relining, Repairing, Rebasing (EBI) (10)

Premarket Exempt

Yes No

Clear

T-Crystal cartridges Light Pink - 07290110500115 Catalog Number : 112501

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

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Light Pink - 07290110500122 Catalog Number : 112502

Device Description : Box of 6 identical cartridges sealed in aluminum bag ;cartridge dimensions : 25m Box of 6 identical cartridges sealed in aluminum bag ;cartridge dimensions : 25mm diameter ; 98mm long ;each cartridge filled with 27Gr of T-Crystal Light Pink Thermoplastic pellets.

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Light Pink - 07290110500139 Catalog Number : 11503

Device Description : Box of 6 identical cartridges sealed in aluminum bag ;cartridge dimensions :25mm Box of 6 identical cartridges sealed in aluminum bag ;cartridge dimensions :25mm diameter ; 82mm long ;each cartridge is filled with 18Gr of T-Crystal Light Pink Thermoplastic pellets.

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Standard Pink - 07290110500146 Catalog Number : 112504

Device Description : box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimension 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.

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Standard Pink - 07290110500153 Catalog Number : 112505

Device Description : Box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimension Box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimensions : 25mm diameter ; 98mm long ;each cartridge filled with 28Gr of T-Crystal Standard Pink Thermoplastic pellets.

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

Perflex T-CRYSTAL - 07290110500160 Catalog Number : 112506

Device Description : Box of 6 Medium cartridges 25mm Diameter and 73mm long,18gr. net of Thermoplasti Box of 6 Medium cartridges 25mm Diameter and 73mm long,18gr. net of Thermoplastic T-CRYSTAL Standard Pink filled inside of each cartridge sealed in aluminum bag,the cartridges are suitable for 25mm thermoplastic injector machines

Device Class : 2

Duns Number: 532176000

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Clear - 07290110500177 Catalog Number : 112507

Device Description : Box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimension Box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimensions : 25mm diameter ; 107mm long ;each cartridge filled with 31Gr of T-Crystal Clear Thermoplastic pellets.

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Clear - 07290110500184 Catalog Number : 112505

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Clear - 07290110500191 Catalog Number : 112509

Device Description : Box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimension 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 Clear Thermoplastic pellets.

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

T-Crystal cartridges Amahari/Purple Pink - 07290110500207 Catalog Number : 112510

Device Description : Box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimension Box of 6 identical cartridges sealed in aluminum vacuum bag ;cartridge dimensions : 25mm diameter ; 107mm long ;each cartridge filled with 31Gr of T-Crystal Amhari/Purple Pink Thermoplastic pellets.

Device Class : 2

Duns Number: 532176000

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : No

Device Count : 1

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