DEVICE: SUPER VIEW® Lens, Disposable Contact, Hassan-Tornambe (00856222004032)

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Device Identifier (DI) Information

SUPER VIEW® Lens, Disposable Contact, Hassan-Tornambe
40417
40417
INSIGHT INSTRUMENTS, INC.
00856222004032
GS1
1
SUPER VIEW® Hassan-Tornambe Disposable Contact Lens for use during vitreo-retinal surgery
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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
Vitrectomy contact lens, single-use A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HJK Lens, Contact, Polymethylmethacrylate, 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: 13 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

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10856222004039 10 00856222004032 In Commercial Distribution Case
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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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