Duns Number:084436906
Device Description: Contact lens remover/inserter with small air channel for hard and gp contact lenses. Sucti Contact lens remover/inserter with small air channel for hard and gp contact lenses. Suction is optional
Catalog Number
515
Brand Name
DMV Magic Touch
Version/Model Number
515
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
K830496,K830496
Product Code
KYE
Product Code Name
Inserter/Remover Contact Lens
Public Device Record Key
cd3b05ca-a78f-41c7-9419-53ffbb3b53bd
Public Version Date
April 14, 2020
Public Version Number
1
DI Record Publish Date
April 06, 2020
Package DI Number
00080875975160
Quantity per Package
10
Contains DI Package
00080875975153
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |