Duns Number:008124539
Device Description: Eye Cups in Sealed Vial
Catalog Number
-
Brand Name
Eye Cups
Version/Model Number
3380
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151575,K151575,K151575
Product Code
LXQ
Product Code Name
Cup, Eye
Public Device Record Key
e157dc79-4f39-4314-9b3c-d9ae46e5299f
Public Version Date
May 03, 2022
Public Version Number
1
DI Record Publish Date
April 25, 2022
Package DI Number
00616784338019
Quantity per Package
6
Contains DI Package
00616784338002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Vial
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |