SMV SCIENTIFIC LLC

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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

3.2mm Stabilizing K-wire - 00810097800281 Catalog Number : 1252-5103-000

Device Description : 3.2mm Stabilizing K-wire

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12mm Drill - 00810097800298 Catalog Number : 1252-4106

Device Description : 12mm Drill

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

7.5 mm Drill - 00810097800304 Catalog Number : 1252-4107

Device Description : 7.5 mm Drill

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

6.0 mm Drill - 00810097800311 Catalog Number : 1252-4108

Device Description : 6.0 mm Drill

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

4.0mm Drill - 00810097800328 Catalog Number : 1252-4109

Device Description : 4.0mm Drill

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

24mm Cannula - 00810097800335 Catalog Number : 1252-5212

Device Description : 24mm Cannula

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12mm Sleeve - 00810097800342 Catalog Number : 1252-4400

Device Description : 12mm Sleeve

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

Impactor - Long - 00810097800359 Catalog Number : 1252-4131

Device Description : Impactor - Long

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

12mm Dilator - 00810097800366 Catalog Number : 1252-4110

Device Description : 12mm Dilator

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

18mm Dilator - 00810097800373 Catalog Number : 1252-4120

Device Description : 18mm Dilator

Device Class : 2

Duns Number: 089645059

Premarket Exempt : Yes

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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