DEVICE: Optego (00360843006233)

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Device Record History
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Device Identifier (DI) Information
Optego
938505-SF
In Commercial Distribution

Optego Vision USA Inc.
00360843006233
GS1

5
835541145 *Terms of Use
Contact Lens Cases, White, 5/pack
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
16581 Contact lens case
A container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LRX Case, Contact Lens
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K112832 000
No 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
7fbd4cd5-f8b7-4fd6-b2d6-300043a08101
March 25, 2022
1
March 17, 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

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

[?]
Unit of Use DI Number: 00360843008961 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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