Fibernex
GUDID B050LF0201X2003
Fibernex 200 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
Laser lithotripsy system| Primary Device ID | B050LF0201X2003 |
| NIH Device Record Key | 9358fad4-e687-42c5-8717-5c2fd0b1b2b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibernex |
| Version Model Number | LF0201X200 |
| 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 | false |
| 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 |
Customer Support Contacts
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com | |
| Phone | 312-888-4064 |
| mchoquette@typenex.com |
Device Dimensions
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B050LF0201X2000 [Primary] |
| HIBCC | B050LF0201X2003 [Package] Contains: B050LF0201X2000 Package: Carton [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050738
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
[B050LF0201X2003]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-27 |
On-Brand Devices [Fibernex]
| 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 |
Trademark Results [Fibernex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBERNEX 88882394 not registered Live/Pending |
Typenex Medical, LLC 2020-04-22 |
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