DUNAMIS MEDICAL, LLC

Address:509 E. Commerce Street,Greenville,AL,36037,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

Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (10)

Premarket Exempt

No Yes

Clear

TightFix Interference Screw PEEK - 00854629006109 Catalog Number : DFX0001T

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

TightFix Interference Screw 9mm - 00854629006116 Catalog Number : DFX0002T

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

TightFix Interference Screw 10mm PEEK - 00854629006123 Catalog Number : DFX0003T

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

TightFix Interference Screw 11mm PEEK - 00854629006130 Catalog Number : DFX0004T

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 3mm Anchor PEEK - 00854629006147 Catalog Number : DFX0028A

Device Description : Suture Anchor 3.0 PEEK SterileSingle Loaded Suture #2 White/Blue Cobraid

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 3.5mm Anchor PEEK - 00854629006161 Catalog Number : DFX0029A

Device Description : Suture Anchor 3.5 PEEK SterileDouble Loaded Sutures #2 White/Blue Cobraid #2 W Suture Anchor 3.5 PEEK SterileDouble Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobraid

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 4.5mm Anchor - 00854629006178 Catalog Number : DFX0030A

Device Description : Suture Anchor 4.5 PEEK SterileSingle Loaded Suture #2 White/Black Cobraid

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 5.5mm Anchor PEEK - 00854629006185 Catalog Number : DFX0031A

Device Description : Suture Anchor 5.5 PEEK SterileDouble Loaded Sutures #2 White/Blue Cobraid #2 Whi Suture Anchor 5.5 PEEK SterileDouble Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobraid

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 6.5mm Anchor PEEK - 00854629006208 Catalog Number : DFX0032A

Device Description : Suture Anchor 6.5 PEEK SterileTriple Loaded Sutures #2 White/Blue Cobraid #2 Wh Suture Anchor 6.5 PEEK SterileTriple Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobraid, #2 White

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 5.5 mm Anchor PEEK - 00854629006215 Catalog Number : DFX0033A

Device Description : Suture Anchor 5.5 PEEK SterileDouble Loaded Sutures #2 Blue Tape #2 White/Black Cobraid

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

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