DEVICE: ETNIA EYEWEAR CULTURE (08435304399925)
Device Identifier (DI) Information
ETNIA EYEWEAR CULTURE
4 SCHNEI 49O PGBK
In Commercial Distribution
Etnia Barcelona, Llc.
4 SCHNEI 49O PGBK
In Commercial Distribution
Etnia Barcelona, Llc.
Frame Spectacle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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).
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d4abb1d9-1b58-4d41-b477-b44730dc999b
February 24, 2023
2
November 28, 2022
February 24, 2023
2
November 28, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
18435304399922 | 10 | 08435304399925 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
305-879-1094
anita.haudebert@etnia.es
anita.haudebert@etnia.es