Duns Number:458670304
Device Description: Carton Label - Eye Wick
Catalog Number
-
Brand Name
Eyetec
Version/Model Number
40-431-USA
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130117,K130117
Product Code
HOZ
Product Code Name
Sponge, Ophthalmic
Public Device Record Key
b17f73fb-6b70-4055-9556-70fa79078400
Public Version Date
February 22, 2021
Public Version Number
3
DI Record Publish Date
August 28, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 329 |
2 | A medical device with a moderate to high risk that requires special controls. | 51 |