DEVICE: SUPER VIEW® Disposable Lens Set, Essential (00856222004056)

Device Identifier (DI) Information

SUPER VIEW® Disposable Lens Set, Essential
40403
In Commercial Distribution
40403
OCULUS SURGICAL INC
00856222004056
GS1

1
015409582 *Terms of Use
SUPER VIEW® Sterile Essential Lens Pack for use with the SUPER VIEW® System and the BIOM®
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47946 Ophthalmic diagnostic condensing lens
An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HJL Lens, Condensing, Diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
Outer Diameter: 18 Millimeter
Outer Diameter: 42 Millimeter
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Device Record Status

a582f69f-ecad-4b3f-b9ad-e32ef39565b9
June 17, 2022
6
September 23, 2016
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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
10856222004053 20 00856222004056 In Commercial Distribution Case
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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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
(772) 236-2622
info@oculussurgical.com
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