Fibernex
GUDID B050LF0201X9403
Fibernex 940 micrometer Reusable Holmium Laser Fibers
TYPENEX MEDICAL LLC
Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system Laser lithotripsy system| Primary Device ID | B050LF0201X9403 |
| NIH Device Record Key | 2a39d713-16c6-4f6e-b94e-4487fafe9210 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibernex |
| Version Model Number | LF0201X940 |
| 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 | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
| Outer Diameter | 940 Micrometer |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B050LF0201X9400 [Primary] |
| HIBCC | B050LF0201X9403 [Package] Contains: B050LF0201X9400 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 |
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
Moist Heat or Steam Sterilization
[B050LF0201X9403]
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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