TYPENEX MEDICAL LLC

Address:303 E Wacker Dr Ste 1030,Chicago,IL,60601,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) (4)

Premarket Exempt

No Yes

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Typenex Surgical Reusable Optical Fiber - B050MF550RST2050 Catalog Number :

Device Description : Reusable 10x, Sterile 550 Micrometer Surgical Optical Fiber RFID

Device Class : 2

Duns Number: 600850213

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Typenex Surgical Single Use Optical Fiber - B050MF550ST2050 Catalog Number :

Device Description : Single Use Sterile 550 Micrometer Optical Fiber RFID

Device Class : 2

Duns Number: 600850213

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Typenex Surgical Reusable Optical Fiber - B050MF800RST2050 Catalog Number :

Device Description : Reusable 10x, Sterile 800 Micrometer Surgical Optical Fiber RFID

Device Class : 2

Duns Number: 600850213

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Typenex Surgical Single Use Optical Fiber - B050MF800ST2050 Catalog Number :

Device Description : Single Use Sterile 800 Micrometer Surgical Optical Fiber RFID

Device Class : 2

Duns Number: 600850213

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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