Fibernex

GUDID B0505LF0101X5503

Laser lithotripsy system

Primary Device ID	B0505LF0101X5503
NIH Device Record Key	86a04fae-e2a1-4d4c-8804-2056982f1e60
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fibernex
Version Model Number	LF0101X550
Company DUNS	600850213
Company Name	TYPENEX MEDICAL LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B0505LF0101X5503 [Package] Contains: B050LF0101X5500 Package: Carton [5 Units] In Commercial Distribution
HIBCC	B050LF0101X5500 [Primary]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	true

B050LF0201X9403	Fibernex 940 micrometer Reusable Holmium Laser Fibers
B050LF0201X5503	Fibernex 550 micrometer Reusable Holmium Laser Fiber
B050LF0201X3653	Fibernex 365 micrometer Reusable Holmium Laser Fiber
B050LF0201X2723	Fibernex 272 micrometer Reusable Holmium Laser Fiber
B050LF0201X2003	Fibernex 200 micrometer Reusable Holmium Laser Fiber
B050LF0101X9403	Fibernex 940 micrometer Single Use Holmium Laser Fiber
B0505LF0101X5503	Fibernex 550 micrometer Single Use Holmium Laser Fiber
B050LF0101X3653	Fibernex 365 micrometer Single Use Holmium Laser Fiber
B050LF0101X2723	Fibernex 272µm Single Use Holmium Laser Fiber
B050LF0101X2003	Fibernex 200µm Single Use Holmium Laser Fiber

Mark Image Registration \| Serial	Company Trademark Application Date
FIBERNEX 88882394 not registered Live/Pending	Typenex Medical, LLC 2020-04-22