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 - 00842048154211 Catalog Number : 97-11G75

Device Description : Tap, Long, F1-MPS, 7.5

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154228 Catalog Number : 97-11G80

Device Description : Tap, Long, F1-MPS, 8.0

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154235 Catalog Number : 97-11G85

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

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154242 Catalog Number : 97-11G90

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

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154259 Catalog Number : 97-11G95

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

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154266 Catalog Number : 97-12G60

Device Description : Tap, Long, F1-MPS, CANN, 6.0

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154273 Catalog Number : 97-12G65

Device Description : Tap, Long, F1-MPS, CANN, 6.5

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154280 Catalog Number : 97-12G70

Device Description : Tap, Long, F1-MPS, CANN, 7.0

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154297 Catalog Number : 97-12G75

Device Description : Tap, Long, F1-MPS, CANN, 7.5

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

DeGen Standard Instrumentation - 00842048154303 Catalog Number : 97-12G80

Device Description : Tap, Long, F1-MPS, CANN, 8.0

Device Class : 1

Duns Number: 078812602

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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