Duns Number:063997360
Device Description: LDR Saline Solution 2x12oz Twin pack
Catalog Number
5513098
Brand Name
LEADER
Version/Model Number
5513098
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
a23ff660-3e4a-45b7-a5a3-6bfcf65ae261
Public Version Date
July 02, 2021
Public Version Number
3
DI Record Publish Date
August 29, 2019
Package DI Number
50096295137137
Quantity per Package
12
Contains DI Package
00096295137132
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |