FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851759007167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851759007167008517590071678517590071670851759007167

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding gogglesA 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
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity25 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-999-2635support@amdlasers.com

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 DIBrandModelCatalogPublished
00851759007006Picasso Plus Dental Diode LaserP810PPLUS2016-09-20
00851759007013Picasso Lite Plus Dental Diode LaserPL810PLPLUS2016-09-20
00851759007020AMD LASERS Bendable Disposable Tips (Assortment of 25)TIP25TIP252016-09-20
00851759007037Bendable Disposable Tips (Box of 25) 400um, 60 degree, 5mmTIP4006005TIP40060052016-09-20
00851759007044Bendable Disposable Tips (Box of 25) 400um, 60 degree, 10mmTIP4006010TIP40060102016-09-20
00851759007051Bendable Disposable Tips (Box of 25) 300um, 60 degree, 5mmTIP3006005TIP30060052016-09-20
00851759007068Bendable Disposable Tips (Box of 25) 300um, 60 degree, 10mmTIP3006010TIP30060102016-09-20
00851759007075Bendable Disposable Tips (Box of 20) 200um, 60 degree, 20mmTIP2006020TIP20060202016-09-20
00851759007082Multi-Tip Handpiece - Picasso Plus (Orange)MTHP-PPLUSMTHP-PPLUS2016-09-20
00851759007099Multi-Tip Handpiece - Picasso Lite Plus (Black)MTHP-PLPLUSMTHP-PLPLUS2016-09-20
00851759007105Quadra TipQTQT2016-09-20
00851759007112Multi-Tip Handpiece - Picasso (Orange)STF400STF4002016-09-20
00851759007129Multi-Tip Handpiece - Picasso Lite (Black)STF200STF2002016-09-20
00851759007136400um Strippable Fiber - FC ConnectionSF400-FCSF400-FC2016-09-20
00851759007143400um Strippable Fiber - Plus SeriesSF400-PLUSSF400-PLUS2016-09-20
00851759007150400um Strippable Fiber - ST ConnectionSF400-STSF400-ST2016-09-20
00851759007174Laser Safety Goggles (fit-over frame)EYEFEYEF2016-09-20

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