Duns Number:006959555
Device Description: MEIJER COLOR CASE LENS CASE SCREW TOP POUCH 1 CT
Catalog Number
-
Brand Name
Meijer Brand
Version/Model Number
CC29
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
K130753,K130753
Product Code
LRX
Product Code Name
Case, Contact Lens
Public Device Record Key
5e75b887-f75a-4b75-b6de-7fbe232cd664
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 04, 2017
Package DI Number
10897522001588
Quantity per Package
324
Contains DI Package
00713733661027
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |