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 - B565FO20131660 Catalog Number : FO-2013-166

Device Description : 1.6 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 - B565FO20132060 Catalog Number : FO-2013-206

Device Description : 2.0 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 - B565FO20140961 Catalog Number : FO-2014-096

Device Description : 0.9 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20141161 Catalog Number : FO-2014-116

Device Description : 1.1 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20141661 Catalog Number : FO-2014-166

Device Description : 1.6 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20142061 Catalog Number : FO-2014-206

Device Description : 2.0 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20142091 Catalog Number : FO-2014-209

Device Description : 2.0 mm K-Wire, 9 Inch Length, Trocar-Blunt-Olive

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20150 Catalog Number : FO-2015

Device Description : Clinical Sizer

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20160960 Catalog Number : FO-2016-096

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

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

Orbitum Staple System - B565FO20161160 Catalog Number : FO-2016-116

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

Device Class : 2

Duns Number: 017138000

Premarket Exempt : No

Product Code : JDR

Prescription Use : Yes

Device Count : 1

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