Duns Number:075390489
Device Description: Ophthalmic Sponge. The CleanTouch PVA Eye Spears are sterile, single-use devices designed Ophthalmic Sponge. The CleanTouch PVA Eye Spears are sterile, single-use devices designed to absorb excess fluids on the human eye.
Catalog Number
ML 100
Brand Name
ML Eyespear
Version/Model Number
ML 100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K002279,K002279,K002279
Product Code
HOZ
Product Code Name
Sponge, Ophthalmic
Public Device Record Key
5b139dec-fa12-484f-a3f0-c6d523d84113
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
50850724001501
Quantity per Package
5000
Contains DI Package
40850724001504
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |