Home GUDID 00851759007167 Laser Safety Goggles (Sport Frame)
Primary DI 00851759007167
Brand Laser Safety Goggles (Sport Frame)
Company AMD Lasers
Model EYE
Catalog number EYE
Device description Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
Published 2016-09-20
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GEX Powered Laser Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEX Powered Laser Surgical Instrument General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851759007167 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00851759007167 00851759007167 851759007167 0851759007167
GMDN Terms# Term, Definition table Term Definition Radiation shielding goggles A personal protective device intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical and dental procedures. It will typically be designed as goggles consisting of a single unit with lenses, side shields, top shields, and bottom shields made from clear lead-equivalent materials, e.g., glass or plastic. The lenses and shields offer additional physical barrier protection from liquid radioactive materials. Goggle lenses may be either uncorrected (non-prescription) or corrected (prescription) for the individual's vision.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Humidity 25 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 15 Degrees Celsius 32 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 25 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 080354039 Device count 1 DM exempt true Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00851759007006 Picasso Plus Dental Diode Laser P810 PPLUS 2016-09-20 00851759007013 Picasso Lite Plus Dental Diode Laser PL810 PLPLUS 2016-09-20 00851759007020 AMD LASERS Bendable Disposable Tips (Assortment of 25) TIP25 TIP25 2016-09-20 00851759007037 Bendable Disposable Tips (Box of 25) 400um, 60 degree, 5mm TIP4006005 TIP4006005 2016-09-20 00851759007044 Bendable Disposable Tips (Box of 25) 400um, 60 degree, 10mm TIP4006010 TIP4006010 2016-09-20 00851759007051 Bendable Disposable Tips (Box of 25) 300um, 60 degree, 5mm TIP3006005 TIP3006005 2016-09-20 00851759007068 Bendable Disposable Tips (Box of 25) 300um, 60 degree, 10mm TIP3006010 TIP3006010 2016-09-20 00851759007075 Bendable Disposable Tips (Box of 20) 200um, 60 degree, 20mm TIP2006020 TIP2006020 2016-09-20 00851759007082 Multi-Tip Handpiece - Picasso Plus (Orange) MTHP-PPLUS MTHP-PPLUS 2016-09-20 00851759007099 Multi-Tip Handpiece - Picasso Lite Plus (Black) MTHP-PLPLUS MTHP-PLPLUS 2016-09-20 00851759007105 Quadra Tip QT QT 2016-09-20 00851759007112 Multi-Tip Handpiece - Picasso (Orange) STF400 STF400 2016-09-20 00851759007129 Multi-Tip Handpiece - Picasso Lite (Black) STF200 STF200 2016-09-20 00851759007136 400um Strippable Fiber - FC Connection SF400-FC SF400-FC 2016-09-20 00851759007143 400um Strippable Fiber - Plus Series SF400-PLUS SF400-PLUS 2016-09-20 00851759007150 400um Strippable Fiber - ST Connection SF400-ST SF400-ST 2016-09-20 00851759007174 Laser Safety Goggles (fit-over frame) EYEF EYEF 2016-09-20
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