INSTRUMENT SPECIALISTS, INC.

Address:32390 IH-10 WEST,BOERNE,TX,78006,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

Table, Operating-Room, Manual (FSE) (10)

Premarket Exempt

Yes

Clear

ISI - 00810045921723 Catalog Number : NT-3750

Device Description : Free Standing Arm Table Traction System

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921730 Catalog Number : NT-CF-4750

Device Description : Carbon Fiber Free Standing Arm Table

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921747 Catalog Number : UL-8000

Device Description : ISI Ultra-Light Specialty Table

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921754 Catalog Number : UL-8050

Device Description : ISI Ultra-Light Specialty Table with Single Post Leg

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921778 Catalog Number : UL-8100

Device Description : Ultra Light Specialty Table with Double Post Leg

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921785 Catalog Number : UL-8150

Device Description : Ultra Light Specialty Table with Under Pad Mounting Bracket and Single Post Leg

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921792 Catalog Number : UL-8200

Device Description : Ultra Light Specialty Table with Under Pad Mounting Bracket and Double Post Leg

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921808 Catalog Number : UL-8300

Device Description : Ultra Light Specialty Table with "T" Post Leg

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921822 Catalog Number : UL-SB-9000

Device Description : Ultra Light Specialty Table w/Slider Brackets

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045921839 Catalog Number : UL-SB-9050

Device Description : Ultra Light Specialty Table w/Slider Brackets with Single Post Leg

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

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