AccessGUDID - DEVICE: Eagle Eyes (00810712013409)

GUDID

Device Identifier (DI) Information

Brand Name: Eagle Eyes
Version or Model: 12005SETLG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12005SETLG
Company Name: Eagle Eyes

Primary DI Number: 00810712013409
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 611195173 *Terms of Use

Device Description: GNM Freedom 55 Set Offer #1 w/ Binoculars (1) Freedom Flash GNM/SLV 55mm or 52mm - Polarized Sunglasses (1) Aviator NL - Night-Lite® Yellow Non-Polarized Glasses (1) Pair of Binoculars and accessories

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):	Yes
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?
46297	Tinted non-prescription spectacle lens	An ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).	Active	false
30045	Hand-held magnifier	A magnifying ophthalmic lens with a handle intended to enlarge text/images for a visually impaired patient/person. It is also known as a magnifying glass and can be made of solid plastic material or glass within a plastic or metal frame.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQY	Sunglasses (Non-Prescription Including Photosensitive)
HJF	Magnifier, Hand-Held, Low-Vision

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6050a141-649e-400a-8e7b-8730851986cc
Public Version Date: August 09, 2021
Public Version Number: 2
DI Record Publish Date: August 31, 2020