Duns Number:828348391
Device Description: 1 Each Sterile Disposable Wide Field Lens for use with the ZEISS RESIGHT®. Distributed by 1 Each Sterile Disposable Wide Field Lens for use with the ZEISS RESIGHT®. Distributed by THEA Surgical (Insight's REF 40424)
Catalog Number
40424
Brand Name
SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®
Version/Model Number
TS-ZR-SV
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HJL
Product Code Name
Lens, Condensing, Diagnostic
Public Device Record Key
424e57d8-a836-4bdc-b797-ddf0eab022f7
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10856222004657
Quantity per Package
20
Contains DI Package
00856222004650
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |