Duns Number:008018525
Device Description: Opti-Free Express Multi-Purpose Disinfecting Solution Twin Pack 2 x 10oz + 2oz
Catalog Number
-
Brand Name
OPTI-FREE EXPRESS
Version/Model Number
OPTI-FREE EXPRESS 2x12oz
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
-
Product Code
LPN
Product Code Name
Accessories, soft lens products
Public Device Record Key
50083a8b-bab1-40d0-9628-b313ff657dc0
Public Version Date
January 24, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20300653145078
Quantity per Package
12
Contains DI Package
00300653144688
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 | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |