DEVICE: MYI OCCLUSION EYE PATCHES (00850029104025)

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Device Record History
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Device Identifier (DI) Information
MYI OCCLUSION EYE PATCHES
009
In Commercial Distribution

Fresnel Prism & Lens Company
00850029104025
GS1

10
789337987 *Terms of Use
PACKET, REGULAR, MYI EYE PATCH
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
61490 Eye patch
A device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
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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
ffd5a4c6-8acd-4221-bd84-2acfbb2f1466
August 27, 2021
6
March 29, 2021
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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
10850029104541 5 00850029104025 In Commercial Distribution PACKETS of 10
10850029104534 3 00850029104025 In Commercial Distribution PACKETS of 10
10850029104633 3 00850029104025 In Commercial Distribution Box
10850029104619 5 00850029104025 In Commercial Distribution Box
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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: 00850029104469 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
952-496-0432
info@fresnelprism.com
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