Duns Number:117592637
Device Description: Ultra-Pure Nutrient Rich Specialty Lens Fill Solution
Catalog Number
-
Brand Name
Nutrifill
Version/Model Number
Nutrifill
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181566,K181566
Product Code
MRC
Product Code Name
Products, Contact Lens Care, Rigid Gas Permeable
Public Device Record Key
c2cb453e-e21c-49be-917c-5400b2bd7acf
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
Package DI Number
10850012123009
Quantity per Package
12
Contains DI Package
00850012123002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |