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

Double Pump Patient cassette - 07350021982001 Catalog Number :

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Double Pump RF Patient cassette - 07350021982506 Catalog Number :

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Double Pump RF - 07350021983039 Catalog Number :

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Foot Control 4-pedal - 07350021983107 Catalog Number :

Device Description : For Double Pump RF or Double Pump

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Foot Control 2-pedal - 07350021983152 Catalog Number :

Device Description : For Double Pump RF or Double Pump

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver Interface Box B1 - 07350021984005 Catalog Number :

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

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver Interface Box B2 - 07350021984012 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 Box B5 - 07350021984043 Catalog Number :

Device Description : For connecting Double Pump RF or Double Pump to BSM PowerTek II Plus, Stryker TP For connecting Double Pump RF or Double Pump to BSM PowerTek II Plus, Stryker TPS, Stryker Core

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver Interface Box B6 - 07350021984050 Catalog Number :

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

Device Class : 2

Duns Number: 097664937

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Shaver Interface Box B10 - 07350021984081 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

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