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) (9) Accessories, Traction (ILZ) (1)

Premarket Exempt

Yes

Clear

ISI - 00810045920504 Catalog Number : PD-125

Device Description : 3" Contoured Foam Pad - Ultra Light / Self Supporting / Free Standing

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920511 Catalog Number : PD-150

Device Description : 4" Contoured Foam Pad - Ultra Light / Self Supporting / Free Standing

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920528 Catalog Number : PD-200

Device Description : 2" Contoured Foam Pad - K Table

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920535 Catalog Number : PD-225

Device Description : 1" Contoured Foam Pad - K Table

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920542 Catalog Number : PD-250

Device Description : 4" Contoured Foam Pad - K Table

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920559 Catalog Number : PD-270

Device Description : 3" Contoured Foam Pad - K Table

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920566 Catalog Number : WS1820

Device Description : Traction Strap

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : ILZ

Prescription Use : No

Device Count : 1

C-Thru - 00810045920573 Catalog Number : C-902100

Device Description : C-Thru Single Post Leg

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920597 Catalog Number : AT-4000

Device Description : Self Supporting Arm Table

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920603 Catalog Number : AT-4300

Device Description : Self Supporting Arm 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

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