3-D MATRIX INC.

Address:1234 Chestnut St.,Newton,MA,02464,US

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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

Polymer, Ear, Nose And Throat, Synthetic, Absorbable (NHB) (3)

Premarket Exempt

Clear

PuraSinus 5mL - 00860001820829 Catalog Number :

Device Description : PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)

Device Class : 2

Duns Number: 058207695

Premarket Exempt : No

Product Code : NHB

Prescription Use : Yes

Device Count : 1

PuraSinus 3mL - 00860001820836 Catalog Number :

Device Description : PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)

Device Class : 2

Duns Number: 058207695

Premarket Exempt : No

Product Code : NHB

Prescription Use : Yes

Device Count : 1

PuraSinus 1mL - 00860001820843 Catalog Number : 651-007

Device Description : PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)

Device Class : 2

Duns Number: 058207695

Premarket Exempt : No

Product Code : NHB

Prescription Use : No

Device Count : 1

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