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) (4)

Premarket Exempt

No Yes

Clear

DeGen Standard Instrumentation - 00842048154815 Catalog Number : 99-42G07

Device Description : Guide Wire, Smooth, NiTi, 2.0mm, Short

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154822 Catalog Number : 99-42G08

Device Description : Guide Wire, Smooth, NiTi, 2.0mm, Long

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154839 Catalog Number : 99-56M

Device Description : Wire Cutter, 6 Inch

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154846 Catalog Number : 99-82M

Device Description : Adapter W Spin Sleeve, 1/4 Square

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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