DEVICE: Sun Designe (00860008278883)

Device Identifier (DI) Information

Sun Designe
83
In Commercial Distribution

John A Taber
00860008278883
GS1

1
134097091 *Terms of Use
Uncut Rx Optical Frame Lenses
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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?
46289 Prescription spectacle lens, non-customized
An ophthalmic lens made of glass or plastic that is manufactured in accordance with a standard prescription (not customized for a specific patient) and intended to be worn in front of the eyes to correct the refractive errors of a patient's eyesight, e.g., refractive ametropia (myopia, hyperopia and astigmatism), and possibly to protect the eyes against radiation or mechanical hazards; it has no additional specialized features. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HQG Lens, Spectacle, Non-Custom (Prescription)
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6eb6a49d-7ff4-4c7c-b13b-8e21ed8e878c
March 17, 2022
1
March 09, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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