DEVICE: IDEAL SiHy/1Month/6PK (00840486901992)

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Device Record History
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Device Identifier (DI) Information
IDEAL SiHy/1Month/6PK
9G14
In Commercial Distribution

VIZIONFOCUS INC.
00840486901992
GS1

1
658860374 *Terms of Use
SiHy/UV/56T/PWR: +0.25
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
47843 Soft corrective contact lens, extended-wear
A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed for continuous overnight wear ranging from 6 to 30 consecutive nights. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it highly permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LPL Lenses, Soft Contact, Daily Wear
MVN Lens, Contact, (Disposable)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K251573 000
No CLOSE

Sterilization
Yes
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
606d612d-10d4-475d-a270-53ef6e2eeac6
February 20, 2026
1
February 12, 2026
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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