AccessGUDID - DEVICE: Etnia Eyewear Culture (08435685073216)

GUDID

Device Identifier (DI) Information

Brand Name: Etnia Eyewear Culture
Version or Model: SHELLEY 53O 15, PT, HV, 53
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Etnia Barcelona, Llc.

Primary DI Number: 08435685073216
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148350593 *Terms of Use

Device Description: Frame Spectacle

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?
32816	Spectacle frame	An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQZ	Frame, Spectacle

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: c184f87e-1ddf-499d-8a82-e5c0984a26fc
Public Version Date: February 24, 2023
Public Version Number: 2
DI Record Publish Date: December 04, 2022