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 - 00842048154518 Catalog Number : 97-31H

Device Description : Counter Torque, E3 Half Tab, RA

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154525 Catalog Number : 97-32P

Device Description : Screw Driver, Cannulated, T25

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154532 Catalog Number : 97-33M-01

Device Description : Ring, 15.7

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154549 Catalog Number : 97-33M-02

Device Description : Ring, 45

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154556 Catalog Number : 97-34R

Device Description : Dilator, 13mm

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154563 Catalog Number : 97-35P

Device Description : Driver Assembly, Guarded

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154570 Catalog Number : 97-36R

Device Description : Dilator, 12.4mm

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154587 Catalog Number : 97-37R

Device Description : Dilator, 12.4mm Single Pass

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154594 Catalog Number : 97-38E

Device Description : Axial Reducer

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154600 Catalog Number : 97-40P10

Device Description : Cervical Plate Awl, 10mm

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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