Duns Number:458670304
Device Description: 1-419B Cellulose Strips Bulk Packed 1 per Unit Non-sterile
Catalog Number
-
Brand Name
Eyetec
Version/Model Number
1-419B
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
Product Code
HOZ
Product Code Name
Sponge, Ophthalmic
Public Device Record Key
57921065-8d87-4b58-be06-e559388dea23
Public Version Date
February 22, 2021
Public Version Number
2
DI Record Publish Date
February 25, 2020
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 |