MED -FIBERS INC.

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

Dislodger, Stone, Basket, Ureteral, Metal (FFL) (7) Powered Laser Surgical Instrument (GEX) (3)

Premarket Exempt

No Yes

Clear

MF-272/300-SD-Flexx - 00855950006301 Catalog Number :

Device Description : Surgical Laser Fiber , 272/300/450, silicone, blue tefzel, NA 0.22, Superdry Con Surgical Laser Fiber , 272/300/450, silicone, blue tefzel, NA 0.22, Superdry Connector® SMA 905, Flexx Trak™ Ball Tip, single use, extension sleeve, EO sterile, label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-365/400-SD-Flexx - 00855950006318 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 SMA 905, Flexx Trak®, single use, extension sleeve, EO sterile, label

Device Class : 2

Duns Number: 058701385

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MF-400-HPCS - 00855950006332 Catalog Number :

Device Description : Surgical Laser Fiber, 400/430/750, hard clad, clear tefzel, NA0.37, standard SMA Surgical Laser Fiber, 400/430/750, hard clad, clear tefzel, NA0.37, standard SMA905, single use, EO sterile, 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-Bas-1.5F-4W-120CM-NTL - 00855950006349 Catalog Number :

Device Description : GrabHold(TM) STONE BASKET 1.5FR 4WIRE 120CM NITINOL- TIPLESS

Device Class : 2

Duns Number: 058701385

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

MF-Bas-1.7F-4W-120CM-NTL - 00855950006356 Catalog Number :

Device Description : GrabHold™ STONE BASKET 1.7FR 4WIRE 120CM NITINOL- TIPLESS

Device Class : 2

Duns Number: 058701385

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

MF-Bas-1.9F-4W-120CM-NTL - 00855950006363 Catalog Number :

Device Description : GrabHold™ STONE BASKET 1.9FR 4WIRE 120CM NITINOL- TIPLESS

Device Class : 2

Duns Number: 058701385

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

MF-Bas-2.2F-4W-120CM-NTL - 00855950006370 Catalog Number :

Device Description : GrabHold™ STONE BASKET 2.2FR 4WIRE 120CM NITINOL- TIPLESS

Device Class : 2

Duns Number: 058701385

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

MF-Bas-2.4F-4W-120CM-NTL - 00855950006387 Catalog Number :

Device Description : GrabHold™ STONE BASKET 2.4FR 4WIRE 120CM NITINOL- TIPLESS

Device Class : 2

Duns Number: 058701385

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

MF-Bas-1.9F-4W-120CM-NTL-F - 00855950006394 Catalog Number :

Device Description : GrabHold(TM) STONE BASKET 1.9FR 4WIRE 120CM NITINOL- TIPLESS-FLEXIBLE

Device Class : 2

Duns Number: 058701385

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

MF-Bas-2.2F-4W-120CM-NTL-F - 00855950006400 Catalog Number :

Device Description : GrabHold(TM) STONE BASKET 2.2FR 4WIRE 120CM NITINOL- TIPLESS-FLEXIBLE

Device Class : 2

Duns Number: 058701385

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

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