Duns Number:946065000
Device Description: Starter Kit contents: Electrical voltage adapter, PuriLens Unit, removable cleaning/disinf Starter Kit contents: Electrical voltage adapter, PuriLens Unit, removable cleaning/disinfecting chamber, two 4-oz. (120-mL) bottles PuriLens Plus Preservative-free Saline, instruction booklet.
Catalog Number
-
Brand Name
PuriLens Plus Disinfecting System
Version/Model Number
MS0610/H
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPN
Product Code Name
Accessories, Soft Lens Products
Public Device Record Key
f603c2f5-66c7-4782-971c-966346e7816b
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |