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-800/880-SBT - 00855950006004 Catalog Number :

Device Description : Surgical Laser Fiber 800/880/1180, silicone, blue tefzel, NA 0.22, damage resist Surgical Laser Fiber 800/880/1180, silicone, blue tefzel, NA 0.22, damage resistant SMA905, single use, gold extensions 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

MFR-1000/1100-HCBT - 00855950006011 Catalog Number :

Device Description : Surgical Laser Fiber 1000/1100/1150/1450, hard clad, blue tefzel, NA 0.22, Absor Surgical Laser Fiber 1000/1100/1150/1450, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SM905, silver extension sleeve, 5x reusable, EO sterile, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MFR-200/240-A - 00855950006028 Catalog Number :

Device Description : Surgical Laser Fiber, 200/240/400, hard clad, blue tefzel, NA 0.22, Absorbing Da Surgical Laser Fiber, 200/240/400, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SM905, 5x reusable, 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

MFR-200/240-SBT - 00855950006035 Catalog Number :

Device Description : Surgical Laser Fiber, 200/240/400, hard clad, blue tefzel, NA 0.22, damage resis Surgical Laser Fiber, 200/240/400, hard clad, blue tefzel, NA 0.22, damage resistant SMA905, 5x reusable, 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

MFR-272/300-A - 00855950006042 Catalog Number :

Device Description : Surgical Laser Fiber 272/300/450, hard clad, blue tefzel, NA 0.22, Absorbing Dar Surgical Laser Fiber 272/300/450, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SM905, blue extension sleeve, 5x reusable, EO sterile, Flat Tip, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MFR-272/300-SBT - 00855950006059 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, 5x reusable, 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

MFR-365/400-A - 00855950006066 Catalog Number :

Device Description : Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dar Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905, 5x reusable, 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

MFR-365/400-SBT - 00855950006073 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 resistant SMA905, 5x reusable, gold extension sleeve, EO sterile, MF label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MFR-550/600-HCBT - 00855950006080 Catalog Number :

Device Description : Surgical Laser Fiber 550/600/780, hard clad, blue tefzel, NA 0.22, damage resist Surgical Laser Fiber 550/600/780, hard clad, blue tefzel, NA 0.22, damage resistant SMA905, 5x reusable, 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

MFR-800/880-SBT - 00855950006097 Catalog Number :

Device Description : Surgical Laser Fiber 800/880/1180, silicone, blue tefzel, NA 0.22, damage resist Surgical Laser Fiber 800/880/1180, silicone, blue tefzel, NA 0.22, damage resistant SMA905, 5 x reusable, gold extensions 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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