DEVICE: SUPER VIEW® Disposable Lens Set for RESIGHT® (00856222004049)
Device Identifier (DI) Information
SUPER VIEW® Disposable Lens Set for RESIGHT®
40219
In Commercial Distribution
40219
INSIGHT INSTRUMENTS, INC.
40219
In Commercial Distribution
40219
INSIGHT INSTRUMENTS, INC.
1 Each RESIGHT® Wide Field Lens and 1 Each Hassan-Tornambe Contact Lens
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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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? |
---|---|---|---|---|
58070 | 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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Active | false |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K051630 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 13 Millimeter |
Outer Diameter: 18 Millimeter |
Device Record Status
23811077-7247-44c5-b347-3e31ea684f56
June 17, 2022
4
September 23, 2016
June 17, 2022
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10856222004046 | 20 | 00856222004049 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(772) 219-9393
CustomerService@InsightInstruments.com
CustomerService@InsightInstruments.com