DEVICE: Typenex Surgical Single Use Optical Fiber (B050MF200ST2050)
Device Identifier (DI) Information
Typenex Surgical Single Use Optical Fiber
MF200ST205
Not in Commercial Distribution
TYPENEX MEDICAL LLC
MF200ST205
Not in Commercial Distribution
TYPENEX MEDICAL LLC
Single Use Sterile 200 Micrometer Surgical Optical Fiber RFID
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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.
|
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 |
---|
Special Storage Condition, Specify: Keep Away from Sunlight |
Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 200 Micrometer |
Device Record Status
a34d9eff-4011-4643-a617-c6c41ad76c10
December 13, 2023
5
August 25, 2016
December 13, 2023
5
August 25, 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 |
---|---|---|---|---|---|
B050MF200ST2051 | 5 | B050MF200ST2050 | 2019-08-07 | Not in Commercial Distribution | Outer 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