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 - 00842048154310 Catalog Number : 97-12G85

Device Description : Tap, Long, F1-MPS, CANN, 8.5

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154327 Catalog Number : 97-12G90

Device Description : Tap, Long, F1-MPS, CANN, 9.0

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154334 Catalog Number : 97-12G95

Device Description : Tap, Long, F1-MPS, CANN, 9.5

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154341 Catalog Number : 97-13N

Device Description : Rod Holder

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154358 Catalog Number : 97-14P

Device Description : Power Driver, T15

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154365 Catalog Number : 97-15R

Device Description : Dilator, Large, Assembly

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154372 Catalog Number : 97-16R

Device Description : Dilator Half Tab Head

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154389 Catalog Number : 97-17R

Device Description : Dilator Sleeve, Half Tab

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154396 Catalog Number : 97-19S-01

Device Description : Distractor Screw to Screw, Right

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154402 Catalog Number : 97-19S-02

Device Description : Distractor Screw to Screw, Left

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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