Duns Number:015409582
Device Description: SUPER VIEW® Sterile Lens Pack for use with the SUPER VIEW® System and the BIOM®
Catalog Number
40411
Brand Name
SUPER VIEW® Disposable Lens Set
Version/Model Number
40411
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
f3b36cae-09f7-4e64-b2f7-de4c207f5643
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
10856222004008
Quantity per Package
20
Contains DI Package
00856222004001
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |