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) (5) Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (5)

Premarket Exempt

No Yes

Clear

DFX Tensile Tape - 00854629006444 Catalog Number : DFX0023S

Device Description : DFX Tensile Tape 2.0 mm (UHMWPE) 18" Blue with a C-7 HALF Circle Taper Point Nee DFX Tensile Tape 2.0 mm (UHMWPE) 18" Blue 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 : Yes

Device Count : 1

DFX Tensile Tape - 00854629006468 Catalog Number : DFX0022S

Device Description : DFX Tensile Tape 2.0 mm (UHMWPE) 30" Blue with a C-7 HALF Circle Taper Point Nee DFX Tensile Tape 2.0 mm (UHMWPE) 30" Blue 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 : Yes

Device Count : 1

Force DFX Suture - 00854629006482 Catalog Number : DFX-2-36-S-WBL-26

Device Description : Force DFX Suture™ #2 (UHMWPE) 36" 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

Force DFX Suture - 00854629006499 Catalog Number : DFX-5-36-S-WBL-48

Device Description : Force DFX Suture™ #5 (UHMWPE) 36" HS48 1/2 Circle Reverse Cutting Needle - 48mm

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

PunchTac - 00854629006512 Catalog Number : DFX0028R

Device Description : 3.0mm Anchor PEEK Preloaded with One #2 DFX Force Suture (UHMWPE)

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac - 00854629006529 Catalog Number : DFX0030R

Device Description : 4.5mm Anchor PEEK Preloaded with One #2 DFX Force Suture ( UHMWPE)

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac - 00854629006536 Catalog Number : DFX0031R

Device Description : 5.5mm Anchor Preloaded with Two #2 DFX Force Suture (UHMWPE)

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Tensile Tape - 00854629006543 Catalog Number : DFX0029S

Device Description : FF TensileTape White Size 2mm 30" heat stiffened cut lengths

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

PunchTac - 00854629006550 Catalog Number : DFX0042A

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

PunchTac - 00854629006574 Catalog Number : DFX0043A

Device Description : 4.75 PunchTac Threaded Anchor PEEK, Preleoaded with Two 2mm Fiber Connect (UHMWPE)

Device Class : 2

Duns Number: 079471560

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

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