Duns Number:084436906
Device Description: Contact lens remover/inserter with suction bulb for scleral contact lenses and handling pr Contact lens remover/inserter with suction bulb for scleral contact lenses and handling prosthetic eyes
Catalog Number
109
Brand Name
DMV Scleral Cup
Version/Model Number
109
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,K830496
Product Code
KYE
Product Code Name
Inserter/Remover Contact Lens
Public Device Record Key
62369b56-75b6-40ec-98fa-1e6c42a63df3
Public Version Date
May 25, 2020
Public Version Number
3
DI Record Publish Date
April 06, 2020
Package DI Number
10080875971091
Quantity per Package
100
Contains DI Package
00080875971094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet (Bag 100pcs)
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |