Duns Number:015409582
Device Description: 1 Each Super View® Sterile Disposable Pivot Lens Sets for use with the BIOM® ml/cl
Catalog Number
54014
Brand Name
Super View® Lens Set, Disposable, Pivot, for BIOM ml/cl
Version/Model Number
54014
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
15fe4c80-80c3-4215-b3ed-707525dc11a7
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 24, 2020
Package DI Number
00852475007196
Quantity per Package
20
Contains DI Package
00852475007189
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 |