Duns Number:071125835
Catalog Number
-
Brand Name
Disposable Iridotomy (VIRIDD)
Version/Model Number
VIRIDD
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HJK
Product Code Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Public Device Record Key
d2d2d25c-9d74-4e03-9307-1689afc6c37f
Public Version Date
September 30, 2020
Public Version Number
4
DI Record Publish Date
September 29, 2016
Package DI Number
30811608018875
Quantity per Package
400
Contains DI Package
00811608018874
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 | 168 |
2 | A medical device with a moderate to high risk that requires special controls. | 92 |