ISTO TECHNOLOGIES INC

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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

Filler, Bone Void, Calcium Compound (MQV) (8)

Premarket Exempt

Clear

InQu - 00865179000004 Catalog Number : IQSP-GR-130

Device Description : 30cc Granules

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

InQu - 00865179000011 Catalog Number : IQSP-GR-110

Device Description : 10cc Granules

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

InQu - 00865179000028 Catalog Number : IQSP-MX-150

Device Description : 5x10cm Matrix

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

InQu - 00865179000035 Catalog Number : IQSP-MX-125

Device Description : 5x5cm Matrix

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

InQu - 00865179000042 Catalog Number : IQSP-PP-110

Device Description : 10cc Paste Mix Plus

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

InQu - 00865179000059 Catalog Number : IQSP-PP-105

Device Description : 5cc Paste Mix Plus

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

InQu - 00865179000066 Catalog Number : IQSP-PP-102

Device Description : 2.5cc Paste Mix Plus

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

InQu - 00865179000073 Catalog Number : IQSP-PP-101

Device Description : 1.25cc Paste Mix Plus

Device Class : 2

Duns Number: 035854152

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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