DEPUY MITEK, LLC

Address:325 Paramount Dr,RAYNHAM,MA,02767,US

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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

ARTHROSCOPE (HRX) (10)

Premarket Exempt

No Yes

Clear

FMS NEXTRA - 10886705000036 Catalog Number : 283225

Device Description : FMS neXtra 2.9mm Mini Ultra-Affressive Cutter Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS NEXTRA - 10886705000050 Catalog Number : 283305

Device Description : FMS neXtra 3.5mm Full Radius Cutter Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS NEXTRA - 10886705000067 Catalog Number : 283315

Device Description : FMS neXtra 3.5mm Aggressive Cutter Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS NEXTRA - 10886705000074 Catalog Number : 283325

Device Description : FMS neXtra 3.5mm Ultra-Aggressive Cutter Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS NEXTRA - 10886705000128 Catalog Number : 283455

Device Description : FMS neXtra 4.0mm Round Burr Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS NEXTRA - 10886705000142 Catalog Number : 283475

Device Description : FMS neXtra 4.0mm Round Tornado Burr Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS NEXTRA - 10886705000234 Catalog Number : 283855

Device Description : FMS neXtra 5.5mm Round Burr Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS NEXTRA - 10886705000258 Catalog Number : 283875

Device Description : FMS neXtra 5.5mm Round Tornado Burr Shaver Blades

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS - 10886705000333 Catalog Number : 287305

Device Description : FMS Full Radius Cutter Shaver Blades 3.5mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS - 10886705000357 Catalog Number : 287315

Device Description : FMS Aggressive Cutter Shaver Blades 3.5mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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