INSIGHTRA MEDICAL, INC.

Address:141 Hatcher Lane,Clarksville,TN,37043,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

Arthroscope (HRX) (10)

Premarket Exempt

No Yes

Clear

Shaver interface Cable C1 - 07350021984203 Catalog Number :

Device Description : For connecting Double Pump RF or Double Pump to ConMed-Linvatec Advantage D 3000

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver interface Cable C2 - 07350021984210 Catalog Number :

Device Description : For connecting Double Pump RF or Double Pump to S&N Dyonics Power, S&N Dyonics Power II

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver interface Cable C5 - 07350021984241 Catalog Number :

Device Description : For connecting Double Pump RF or Double Pump to Arthrex APS II

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver interface Cable C6 - 07350021984258 Catalog Number :

Device Description : For connecting Double Pump RF or Double Pump to Atlantech Revolution, FMS Duo+

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver interface Cable C8 - 07350021984272 Catalog Number :

Device Description : For connecting Double Pump RF or Double Pump to Eberle C2

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver interface Cable C15 - 07350021984340 Catalog Number :

Device Description : For connecting Double Pump RF or Double Pump to Biomet Sports Medicine PowerTek II Plus

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

RF Cable A1 - 07350021984517 Catalog Number :

Device Description : For connecting Double Pump RF to S&N Dyonics RF, ArthroCare Atlas, ArthroCare Qu For connecting Double Pump RF to S&N Dyonics RF, ArthroCare Atlas, ArthroCare Quantum and ArthroCare Quantum 2

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

RF Cable A2 - 07350021984524 Catalog Number :

Device Description : For connecting Double Pump RF to Stryker Serfas Energy

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

PowerPumpTM dp System - 17350021986105 Catalog Number :

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

PowerPumpTM dp System Day Cassette - 17350021986129 Catalog Number :

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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