Duns Number:828348391
Device Description: 1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distr 1 Each 40414 RESIGHT® Wide Field Lens and 1 Each 40417 Hassan-Tornambe Contact Lens. Distributed by THEA Surgical (Insight's REF 40226)
Catalog Number
40226
Brand Name
SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®
Version/Model Number
TS-ZR-LS
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"
-
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
K051630,K051630
Product Code
HJK
Product Code Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Public Device Record Key
6e78b8d5-b206-443d-b36c-f3a7c245095b
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10856222004060
Quantity per Package
20
Contains DI Package
00856222004063
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 |