ADVANCED RESEARCH MEDICAL LLC

Address:1515 HIGHWAY 13 EAST,Burnsville,MN,55337,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

Sacroiliac Joint Fixation (OUR) (10)

Premarket Exempt

No Yes

Clear

Advanced Research Medical Trident SI Screw System - 00840239800305 Catalog Number : 03-11-1

Device Description : Dilator - 8mm

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800312 Catalog Number : 03-11-2

Device Description : Dilator - 22mm

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800329 Catalog Number : 03-13

Device Description : Insulating Sleeve

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800336 Catalog Number : 03-2001-300

Device Description : Trident Primary Screw Caddy and Lid

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800343 Catalog Number : 03-2001-400

Device Description : Trident Optional Screw Caddy and Lid

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800350 Catalog Number : 03-2001

Device Description : Trident Case Assembly

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800367 Catalog Number : 03-100

Device Description : 1/4" Square Quick Connect Palm Handle

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800374 Catalog Number : 03-14

Device Description : Measuring Sleeve

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800381 Catalog Number : 03-210

Device Description : 1/4" Square Quick Connect Ratcheting Tee Cannulated Handle

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Advanced Research Medical Trident SI Screw System - 00840239800442 Catalog Number : 03-08

Device Description : Awl

Device Class : 2

Duns Number: 117201206

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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