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) (6) Accessories, Traction (ILZ) (4)

Premarket Exempt

Yes

Clear

C-Thru - 00810045920368 Catalog Number : C-902155 CUSTOM 14 x 14

Device Description : C-Thru Hand Table 14" Wide, with 14" operative end and 25" end

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

C-Thru - 00810045920375 Catalog Number : C-902155 CUSTOM 24/20

Device Description : C-Thru Hand Table 15.5" Wide with 20" and 24" ends

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

C-Thru - 00810045920382 Catalog Number : C-902155 CUSTOM 35/25

Device Description : C-Thru Hand Table 20" Wide with 25" and 35" ends

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920436 Catalog Number : K-705

Device Description : Universal Under Pad Mounting Bracket (incl. 2 Large Round Knobs)

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : FSE

Prescription Use : No

Device Count : 1

ISI - 00810045920443 Catalog Number : K3278

Device Description : Extra Small Stainless Finger Trap

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : ILZ

Prescription Use : No

Device Count : 1

ISI - 00810045920450 Catalog Number : K3280

Device Description : Small Stainless Finger Trap

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : ILZ

Prescription Use : No

Device Count : 1

ISI - 00810045920467 Catalog Number : K3285

Device Description : Medium Stainless Finger Trap

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : ILZ

Prescription Use : No

Device Count : 1

ISI - 00810045920474 Catalog Number : K3290

Device Description : Large Stainless Finger Trap

Device Class : 1

Duns Number: 041517095

Premarket Exempt : Yes

Product Code : ILZ

Prescription Use : No

Device Count : 1

ISI - 00810045920481 Catalog Number : PD-050

Device Description : 1" 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 - 00810045920498 Catalog Number : PD-100

Device Description : 2" 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

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