Duns Number:085668598
Device Description: E.DL 90D LENS Box of 10 use 196 740
Catalog Number
-
Brand Name
E.DL 90D LENS
Version/Model Number
196 744
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
-
Product Code
HJK
Product Code Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Public Device Record Key
41a7783b-68ba-4b5a-8121-6a8ff9a46be0
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
10841668111830
Quantity per Package
10
Contains DI Package
00841668111833
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1518 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| U | Unclassified | 63 |