DEGEN MEDICAL, INC.

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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

Orthopedic manual surgical instrument (LXH) (10)

Premarket Exempt

No Yes

Clear

DeGen Standard Instrumentation - 00842048154419 Catalog Number : 97-20P

Device Description : Screwdriver, Self Retaining Cervical, Solid Cap

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154426 Catalog Number : 97-21P

Device Description : Driver, T-30 Stab and Grab Modular

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154433 Catalog Number : 97-22M

Device Description : Head Positioner MIS Half Tab

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154440 Catalog Number : 97-23M

Device Description : Sharp Wanding Blade Assembly

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154457 Catalog Number : 97-24P

Device Description : Self-Retaining Driver, T30

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154464 Catalog Number : 97-25S

Device Description : Anterior Cervical Distractor Forceps

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154471 Catalog Number : 97-26P

Device Description : Self-Retaining Driver T30 Molded Handle

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154488 Catalog Number : 97-27E

Device Description : Sagittal Bender 5.5mm, Right

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154495 Catalog Number : 97-28E

Device Description : Sagittal Bender 5.5mm, Left

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154501 Catalog Number : 97-30M

Device Description : Driver Shaft Guard Assy

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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