AccessGUDID - DEVICE: Typenex Surgical Reusable Optical Fiber (B050MF800RST2050)

GUDID

Device Identifier (DI) Information

Brand Name: Typenex Surgical Reusable Optical Fiber
Version or Model: MF800RST205
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TYPENEX MEDICAL LLC

Primary DI Number: B050MF800RST2050
Issuing Agency: HIBCC
Commercial Distribution End Date: December 23, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 600850213 *Terms of Use

Device Description: Reusable 10x, Sterile 800 Micrometer Surgical Optical Fiber RFID

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide

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: 800 Micrometer

Device Record Status

Public Device Record Key: 8758f43a-cdf4-4fb0-b833-ba71b040701c
Public Version Date: December 13, 2023
Public Version Number: 5
DI Record Publish Date: September 06, 2016