DEVICE: SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT® (00856222004827)

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Device Identifier (DI) Information

SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT®
40414
40414
INSIGHT INSTRUMENTS, INC.
00856222004827
GS1
1
1 Each Sterile Disposable RESIGHT® Wide Field Lens
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Diagnostic condensing lens An ophthalmic lens used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) to focus reflected light from the fundus of the eye. Compared to direct ophthalmosocoy, the indirect method enables better viewing of the peripheral region of the fundus out to the ora serrata (serrated junction between the retina and the ciliary body).
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FDA Product Code

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Product Code Product Code Name
HJL Lens, Condensing, Diagnostic
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 18 Millimeter
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Device Status

In Commercial Distribution
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
No Package DIs found
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Secondary DI

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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) 219-9393
CustomerService@InsightInstruments.com
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