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) (7) Washer, Bolt Nut (HTN) (3) Bit, Drill (HTW) (2) Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (2)

Premarket Exempt

No Yes

Clear

PunchTac - 00854629006598 Catalog Number : DFX0044A

Device Description : 3.0mm PunchTac Knotless Anchor Peek

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Punchtac - 00854629006604 Catalog Number : DFX0027A

Device Description : 3.0mm PunchTac Anchor Peek, Preloaded with Two #2 Force Suture (UHMWPE)

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac - 00854629006628 Catalog Number : DFX0044

Device Description : 3.0mm PunchTac Knotless Anchor PEEK

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac - 00854629006635 Catalog Number : DFX0027R

Device Description : 3.0mm PunchTac Anchor Peek, Preloaded with Two #2 Force Suture (UHMWPE)

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

DFX Tensile Tape - 00854629006659 Catalog Number : DFX0032S

Device Description : 2mm Blue 39" FiberConnect

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

Tensile Tape - 00854629006666 Catalog Number : DFX0031S

Device Description : 1.5mm Blue 38" Tensile Tape

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

Constrictor - Syndesmosis Knotless Adjustable Button System - 00854629006697 Catalog Number : AB-2200

Device Description : Dunamis Adjustable Fixation Button System

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : HTN, MBI

Prescription Use : Yes

Device Count : 1

Syndesmosis Repair Implantation System - 00854629006703 Catalog Number : AB-2250

Device Description : Syndesmosis Repair Implantation System

Device Class : 1

Duns Number: 079471560

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Syndex with Constrictor® Technology - 00854629006727 Catalog Number : MSYN0000

Device Description : Syndex with Constrictor® Technology for Syndesmosis Repair

Device Class : 1

Duns Number: 079471560

Premarket Exempt : No

Product Code : HTN, MBI, HTW

Prescription Use : Yes

Device Count : 1

Constrictor® Mini for Syndesmosis Repair - 00854629006734 Catalog Number : AB-3000

Device Description : Dunamis Mini Adjustable Fixation Button System

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : HTN, MBI

Prescription Use : Yes

Device Count : 1

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