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 - 00842048154716 Catalog Number : 97-75G

Device Description : 7.5mm Solid tap

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154723 Catalog Number : 99-38M

Device Description : Adapter, Male Hex, 1/4 Drive

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154730 Catalog Number : 99-39M

Device Description : Adapter, Female Hex, A/O Drive

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154747 Catalog Number : 99-40M

Device Description : Adapter, Female Hex, 1/4 Drive

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154754 Catalog Number : 99-42G01

Device Description : Guide Wire, Smooth, 316LVM, 1.4mm, Short

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154761 Catalog Number : 99-42G02

Device Description : Guide Wire, Smooth, 316LVM, 1.4mm, Long

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154778 Catalog Number : 99-42G03

Device Description : Guide Wire, Smooth, 316LVM, 2.0mm, Short

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154785 Catalog Number : 99-42G04

Device Description : Guide Wire, Smooth, 316LVM, 2.0mm, Long

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154792 Catalog Number : 99-42G05

Device Description : Guide Wire, Smooth, NiTi, 1.4mm, Short

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154808 Catalog Number : 99-42G06

Device Description : Guide Wire, Smooth, NiTi, 1.4mm, Long

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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