MED -FIBERS INC.

Address:7404 W Detroit St Ste 140,Chandler,AZ,85226,US

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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

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

No Yes

Clear

MF-272/300-SBT-DT - 00855950006530 Catalog Number :

Device Description : Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905, blue boot, single use, blue extension sleeve, Dome Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

00855950006547 - 00855950006547 Catalog Number :

Device Description : Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905 SMA 905 HHz connector(TM), blue boot, single use, blue extension sleeve, Dome Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

MF-150/180-HHz - 00855950006554 Catalog Number :

Device Description : Surgical Laser Fiber 150/180/220/350 micron, silicone, blue tefzel, NA 0.22, SMA Surgical Laser Fiber 150/180/220/350 micron, silicone, blue tefzel, NA 0.22, SMA 905 HHz connector(TM), extension sleeve, boot, dust cap, single use, sterile, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MFR-150/180-HHz - 00855950006561 Catalog Number :

Device Description : Surgical Laser Fiber 150/180/210/350 micron, hard clad, blue tefzel, NA 0.22, SM Surgical Laser Fiber 150/180/210/350 micron, hard clad, blue tefzel, NA 0.22, SMA 905 HHz connector(TM), boot, reusable, silver extension sleeve, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-600/630-RM - 00865325000100 Catalog Number :

Device Description : 600 Micron RADIAL TIP Laser Fiber with markings, 600/630/660/950 WN, NA 0.22, si 600 Micron RADIAL TIP Laser Fiber with markings, 600/630/660/950 WN, NA 0.22, silica/silica, SMA 905 connector, silver extension sleeve, black boot, 2.5m, double packed, single use, EO sterile

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-400/440-RM - 00865325000117 Catalog Number :

Device Description : 400 Micron RADIAL TIP Laser Fiber with markings, 400/440/950 WN, NA 0.22, silica 400 Micron RADIAL TIP Laser Fiber with markings, 400/440/950 WN, NA 0.22, silica/silica, SMA 905 connector, silver extension sleeve, black boot, 2.5m, double packed, single use, EO sterile

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-272/300-SBT - 00865325000124 Catalog Number :

Device Description : Surgical Laser Fiber 272/300/450, silicone, blue tefzel, NA 0.22, damage resista Surgical Laser Fiber 272/300/450, silicone, blue tefzel, NA 0.22, damage resistant SMA905, single use, blue extension sleeve, EO sterile, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-365/400-SBT - 00865325000131 Catalog Number :

Device Description : Surgical Laser Fiber 365/400/470/580, silicone, blue tefzel, NA 0.22, damage res Surgical Laser Fiber 365/400/470/580, silicone, blue tefzel, NA 0.22, damage resistent SMA905, single use, gold extension sleeve, EO sterile, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-550/600-HCBT - 00865325000148 Catalog Number :

Device Description : Surgical Laser Fiber 550/600/750, hard clad, blue tefzel, NA 0.22, damage resis Surgical Laser Fiber 550/600/750, hard clad, blue tefzel, NA 0.22, damage resistent SMA 905, single use, silver extension sleeve, EO sterile, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-1000/1100-HCBT - 00865325000155 Catalog Number :

Device Description : Surgical Laser Fiber 1000/1100/1150/1450, hard clad, blue tefzel, NA 0.22, damag Surgical Laser Fiber 1000/1100/1150/1450, hard clad, blue tefzel, NA 0.22, damage resistant SMA905, single use, red extension sleeve, EO sterile, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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