DEVICE: MYI OCCLUSION EYE PATCHES (00850029104025)
Device Identifier (DI) Information
MYI OCCLUSION EYE PATCHES
009
In Commercial Distribution
Fresnel Prism & Lens Company
009
In Commercial Distribution
Fresnel Prism & Lens Company
PACKET, REGULAR, MYI EYE PATCH
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
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 |
---|
No Device Sizes |
Device Record Status
ffd5a4c6-8acd-4221-bd84-2acfbb2f1466
August 27, 2021
6
March 29, 2021
August 27, 2021
6
March 29, 2021
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00850029104469
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
952-496-0432
info@fresnelprism.com
info@fresnelprism.com