Duns Number:051957769
Device Description: Contact Lens Case,3 PackFLAT BED SOAKING LENS CASE – 3 PACK. THESE CONTACT LENS CASES ARE Contact Lens Case,3 PackFLAT BED SOAKING LENS CASE – 3 PACK. THESE CONTACT LENS CASES ARE MOLDED PLASTIC, FLAT STYLE CASES WITH SCREW TOP LIDS, SIMILAR IN DESIGN TO CURRENTLY MARKETED PRODUCTS. THE FLAT BED STYLE OF CONTACT LENS CASES ARE FOR STORAGE OF SOFT (HYDROPHYLLIC), RIGID GAS PERMEABLE (RGP), AND HARD CONTACT LENSES DURING CHEMICAL DISINFECTION.
Catalog Number
-
Brand Name
EQUATE
Version/Model Number
SC-206
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
K991206,K991206
Product Code
LRX
Product Code Name
Case, Contact Lens
Public Device Record Key
3d4c8d31-ca99-4e22-bbb7-6493dc0cb2c1
Public Version Date
November 02, 2018
Public Version Number
1
DI Record Publish Date
October 02, 2018
Package DI Number
10681131080979
Quantity per Package
3
Contains DI Package
00681131080972
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |