DEVICE: Typenex Surgical Single Use Optical Fiber (B050MF800ST2050)

Device Identifier (DI) Information

Typenex Surgical Single Use Optical Fiber
MF800ST205
In Commercial Distribution

TYPENEX MEDICAL LLC
B050MF800ST2050
HIBCC

1
600850213 *Terms of Use
Single Use Sterile 800 Micrometer Surgical Optical Fiber RFID
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131473 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
Special Storage Condition, Specify: Keep Dry
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 800 Micrometer
CLOSE

Device Record Status

d7731c68-5bd3-4283-ab7d-862f3158d859
July 06, 2018
3
August 26, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B050MF800ST2051 5 B050MF800ST2050 In Commercial Distribution Outer Carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
312-888-4064
mchoquette@typenex.com
CLOSE