ACIST MEDICAL SYSTEMS, INC.

Address:7905 FULLER ROAD,EDEN PRAIRIE,MN,55344,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

Injector And Syringe, Angiographic (DXT) (10)

Premarket Exempt

Clear

AngioTouch® Kit - 10841716100120 Catalog Number :

Device Description : Model AT P54, p/n 700608-035Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 700608-035Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100137 Catalog Number :

Device Description : Model AT P54, p/n 700608-039Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 700608-039Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100144 Catalog Number :

Device Description : Model AT P54, p/n 700608-040Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 700608-040Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100151 Catalog Number :

Device Description : Model AT P54, p/n 700608-041Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 700608-041Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100168 Catalog Number :

Device Description : Model AT P54, p/n 700608-042Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 700608-042Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100175 Catalog Number :

Device Description : Model AT P54, p/n 701278-002Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 701278-002Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100199 Catalog Number :

Device Description : Model AT P54, p/n 701278-006Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 701278-006Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100212 Catalog Number :

Device Description : Model AT P65, p/n 701554-001Kit Contents: hand controller, 3-way high-pressure s Model AT P65, p/n 701554-001Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100229 Catalog Number :

Device Description : Model AT P65, p/n 701554-002Kit Contents: hand controller, 3-way high-pressure s Model AT P65, p/n 701554-002Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100236 Catalog Number :

Device Description : Model AT P65, p/n 701564-001Kit Contents: hand controller, 3-way high-pressure s Model AT P65, p/n 701564-001Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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