Duns Number:015272206
Device Description: Silicone eye sphere, 19.0mm diameter, packaged individually, non-sterile, disposable, box Silicone eye sphere, 19.0mm diameter, packaged individually, non-sterile, disposable, box of 1
Catalog Number
4126E
Brand Name
Ambler Surgical
Version/Model Number
4126E
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
K112176
Product Code
HPZ
Product Code Name
IMPLANT, EYE SPHERE
Public Device Record Key
0fa7fa20-13ba-4820-9c97-632d68a8269e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2016
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |