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

Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (6) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (4)

Premarket Exempt

No Yes

Clear

PunchTac 3.0mm Anchor PEEK - 00854629006239 Catalog Number : DFX0034A

Device Description : Suture Anchor 3.0 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 - 00854629006253 Catalog Number : DFX0035A

Device Description : 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape ( 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape (UHMWPE) Sterile Single Use

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 5.5 Anchor PEEK - 00854629006277 Catalog Number : DFX0036A

Device Description : 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two #2 DFX Force Suture (U 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two #2 DFX Force Suture (UHMWPE) and One 1.5mm DFX Tensile Tape (UHMWPE) Sterile Single Use

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac 6.5 mm Anchor PEEK - 00854629006291 Catalog Number : DFX0037A

Device Description : 6.5 mm PunchTac™ Threaded Anchor PEEK Preloaded with Two #2 DFX Force Suture a 6.5 mm PunchTac™ Threaded Anchor PEEK Preloaded with Two #2 DFX Force Suture and One 1.5mm DFX Tensile Tape (UHMWPE) Sterile Single Use

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

DFX Tensile Tape - 00854629006352 Catalog Number : DFX0025S

Device Description : DFX Tensile Tape 1.5 mm (UHMWPE) 18" White HC-5 1/2 Circle Taper Point Needle - 25.9mm

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

DFX Tensile Tape - 00854629006376 Catalog Number : DFX0024S

Device Description : DFX Tensile Tape 1.5 mm (UHMWPE) 30" White HC-5 1/2 Circle Taper Point Needle - 25.9mm

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

DFX Tensile Tape - 00854629006383 Catalog Number : DFX0027S

Device Description : DFX Tensile Tape 1.5 mm (UHMWPE) 18" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : No

Device Count : 1

DFX Tensile Tape - 00854629006390 Catalog Number : DFX0026S

Device Description : DFX Tensile Tape 1.5 mm (UHMWPE) 30" Blue HC-5 1/2 Circle Taper Point Needle - 25.9mm

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : No

Device Count : 1

DFX Tensile Tape - 00854629006413 Catalog Number : DFX0021S

Device Description : DFX Tensile Tape 2.0 mm (UHMWPE) 18" White with a C-7 HALF Circle Taper Point Ne DFX Tensile Tape 2.0 mm (UHMWPE) 18" White with a C-7 HALF Circle Taper Point Needle - 38.9mm

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : No

Device Count : 1

DFX Tensile Tape - 00854629006437 Catalog Number : DFX0020S

Device Description : DFX Tensile Tape 2.0 mm (UHMWPE) 30" White with a C-7 HALF Circle Taper Point Ne DFX Tensile Tape 2.0 mm (UHMWPE) 30" White with a C-7 HALF Circle Taper Point Needle - 38.9mm

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : No

Device Count : 1

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