Single use Surgical Optical Fiber

GUDID 08059173391202

Single use ball-tip 272 micron Sterile Surgical Optical Fiber

QUANTA SYSTEM SPA

Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use
Primary Device ID08059173391202
NIH Device Record Keyfdc38bed-c7ec-4d13-a72c-0ad0adee6c4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle use Surgical Optical Fiber
Version Model NumberOAF302721
Company DUNS436045833
Company NameQUANTA SYSTEM SPA
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391196 [Primary]
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391202 [Package]
Contains: 08059173391196
Package: carton box [5 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS108059173391677 [Package]
Package: carton box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

Devices Manufactured by QUANTA SYSTEM SPA

08059173391202 - Single use Surgical Optical Fiber2020-06-17Single use ball-tip 272 micron Sterile Surgical Optical Fiber
08059173391202 - Single use Surgical Optical Fiber2020-06-17 Single use ball-tip 272 micron Sterile Surgical Optical Fiber
08033945936969 - Thunder 2020-02-06
08033945936976 - Thunder VT2020-02-06
08033945936983 - Thunder HR2020-02-06
08033945937638 - 5852020-02-06
08033945938857 - DenaVe2020-02-06
08059173390960 - Litho EVO2020-02-04
08033945935009 - Twain Evo2019-10-09 Intense Pulsed Light handpiece (Removable waveguide)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.