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

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (7) FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE (MBI) (2) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT (HWE) (1)

Premarket Exempt

Yes No

Clear

HEALIX TI PERMACORD - 10886705025503 Catalog Number : 223150

Device Description : HEALIX Ti ANCHOR w/ PERMACORD Titanium Anchor (1) Blue (1) White/Black, Size 2 ( HEALIX Ti ANCHOR w/ PERMACORD Titanium Anchor (1) Blue (1) White/Black, Size 2 (5 metric) PERMACORD Suture, 36 Inches (91cm) 5.5mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

HEALIX TI PERMACORD - 10886705025510 Catalog Number : 223151

Device Description : HEALIX Ti 3-SUTURE ANCHOR w/ PERMACORD Titanium Anchor (1) Blue (1) White/Black HEALIX Ti 3-SUTURE ANCHOR w/ PERMACORD Titanium Anchor (1) Blue (1) White/Black (1) White/Green, Size 2 (5 metric) PERMACORD Suture, 36 Inches (91cm) 5.5mm

Device Class : 2

Duns Number: 190572854

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

GRYPHON - 10886705025527 Catalog Number : 211601

Device Description : GRYPHON HARD BONE DRILL

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

NA - 10886705025534 Catalog Number : 211603

Device Description : SMALL SOFT TISSUE DILATOR

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 10886705025541 Catalog Number : 211604

Device Description : MEDIUM SOFT TISSUE DILATOR

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 10886705025558 Catalog Number : 211605

Device Description : LARGE SOFT TISSUE DILATOR

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 10886705025572 Catalog Number : 211607

Device Description : MEDIUM U-SHAPED CANNULA

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 10886705025589 Catalog Number : 211608

Device Description : LARGE U-SHAPED CANNULA

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 10886705025602 Catalog Number : 211610

Device Description : OBTURATOR, MEDIUM U-SHAPED CANNULA

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NA - 10886705025619 Catalog Number : 211611

Device Description : OBTURATOR, LARGE U-SHAPED CANNULA

Device Class : 1

Duns Number: 190572854

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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