Typenex Surgical Single Use Optical Fiber

GUDID B050MF550ST2051

Single Use Sterile 550 Micrometer Optical Fiber RFID

TYPENEX MEDICAL LLC

Laser lithotripsy system
Primary Device IDB050MF550ST2051
NIH Device Record Keyb0a68618-3116-4458-a063-b40c53b124c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTypenex Surgical Single Use Optical Fiber
Version Model NumberMF550ST205
Company DUNS600850213
Company NameTYPENEX MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com
Phone312-888-4064
Emailmchoquette@typenex.com

Device Dimensions

Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Kep Dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB050MF550ST2050 [Primary]
HIBCCB050MF550ST2051 [Package]
Contains: B050MF550ST2050
Package: Outer Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-26

On-Brand Devices [Typenex Surgical Single Use Optical Fiber]

B050MF800ST2051Single Use Sterile 800 Micrometer Surgical Optical Fiber RFID
B050MF550ST2051Single Use Sterile 550 Micrometer Optical Fiber RFID
B050MF365ST2051Single Use Sterile 365 Micrometer Optical Fiber RFID
B050MF272ST2051Single Use Sterile 272 Micrometer Surgical Optical Fiber RFID
B050MF200ST2051Single Use Sterile 200 Micrometer Surgical Optical Fiber RFID
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.