AccessGUDID - DEVICE: Laser Safety Goggles (Sport Frame) (00851759007167)

GUDID

Device Identifier (DI) Information

Brand Name: Laser Safety Goggles (Sport Frame)
Version or Model: EYE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EYE
Company Name: AMD Lasers

Primary DI Number: 00851759007167
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 080354039 *Terms of Use

Device Description: Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38884	Radiation shielding goggles/spectacles	A personal protective device in the form of eyewear/glasses with clear lenses 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 procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 50 Degrees Celsius
Storage Environment Humidity: between 25 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 15 and 32 Degrees Celsius
Handling Environment Humidity: between 25 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00c80030-b120-4905-b53e-8cb8f589604d
Public Version Date: November 03, 2020
Public Version Number: 3
DI Record Publish Date: September 20, 2016