Duns Number:946065000
Device Description: PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solu PuriLens Plus Preservative-Free Saline is a sterile, non-preserved, aqueous, isotonic solution of sodium chloride, buffered with boric acid and sodium borate. PuriLens Plus Preservative-Free Saline is sterilized and packaged using aseptic processing (blow- fill-seal).
Catalog Number
-
Brand Name
PuriLens Plus Preservative Free Saline
Version/Model Number
2 oz. (60 mL) Bottle
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
7c6034ca-199b-4099-9201-b00803f31f1b
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 24, 2021
Package DI Number
00830002000100
Quantity per Package
6
Contains DI Package
00830002000094
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |