DEVICE: Fibernex (B050LF0201X2000)
Device Identifier (DI) Information
Fibernex
LF0201X200
Not in Commercial Distribution
TYPENEX MEDICAL LLC
LF0201X200
Not in Commercial Distribution
TYPENEX MEDICAL LLC
Fibernex 200 micrometer Reusable Holmium Laser Fiber
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36037 | Laser lithotripsy system |
An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragment. The debris may be removed forcefully or passed out later by natural means.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 200 Micrometer |
Device Record Status
9358fad4-e687-42c5-8717-5c2fd0b1b2b8
December 13, 2023
4
December 27, 2016
December 13, 2023
4
December 27, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B050LF0201X2003 | 5 | B050LF0201X2000 | 2017-01-01 | Not in Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
312-888-4064
mchoquette@typenex.com
mchoquette@typenex.com