CPM MEDICAL CONSULTANTS, 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

Staple, Fixation, Bone (JDR) (10)

Premarket Exempt

Clear

Orbitum Staple System - B565FO20030 Catalog Number : FO-2003

Device Description : Tamp

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO2004120 Catalog Number : FO-2004-12

Device Description : 12mm Punch

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO2004160 Catalog Number : FO-2004-16

Device Description : 16mm Punch

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO2004200 Catalog Number : FO-2004-20

Device Description : 20mm Punch

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20060 Catalog Number : FO-2006

Device Description : Drill Template

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO2007121 Catalog Number : FO-2007-12

Device Description : Punch VI 12mm

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO2007161 Catalog Number : FO-2007-16

Device Description : Punch VI 16mm

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO2007201 Catalog Number : FO-2007-20

Device Description : Punch VI 20mm

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20130960 Catalog Number : FO-2013-096

Device Description : 0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20131160 Catalog Number : FO-2013-116

Device Description : 1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

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