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) (7) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (3)

Premarket Exempt

Yes No

Clear

FMS - 10886705025091 Catalog Number : 283478

Device Description : FMS XL ROUND TORNADO BURR PLUS 4.0mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS - 10886705025107 Catalog Number : 283858

Device Description : FMS XL ROUND BURR PLUS 5.0mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS - 10886705025114 Catalog Number : 283878

Device Description : FMS XL ROUND TORNADO BURR PLUS 5.0mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

EXPRESSEW - 10886705025190 Catalog Number : 214157

Device Description : EXPRESSEW III AutoCapture Flexible Suture Passer

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

EXPRESSEW - 10886705025206 Catalog Number : 214158

Device Description : EXPRESSEW III Autocapture Loading Tool Retention Plate For use with AutoCapture EXPRESSEW III Autocapture Loading Tool Retention Plate For use with AutoCapture Flexible Suture Passer

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

EXPRESSEW - 10886705025213 Catalog Number : 214159

Device Description : EXPRESSEW III AutoCapture Combo Kit

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

FMS - 10886705025428 Catalog Number : 283459

Device Description : FMS Round Burr Plus 4.0mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS - 10886705025435 Catalog Number : 283479

Device Description : FMS Round Tornado Burr Plus 4.0mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS - 10886705025442 Catalog Number : 283859

Device Description : FMS Round Burr Plus 5.0mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

FMS - 10886705025497 Catalog Number : 283879

Device Description : FMS Round Tornado Burr Plus 5.0mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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