Duns Number:257382580
Device Description: Acrylic and silicone spheres are permanent implants used to replace the lost volume and to
Catalog Number
-
Brand Name
Silicone Spheres (22 mm, 5.6 cc)
Version/Model Number
11-222
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2020
Issuing Agency
In HIBCC
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
HPZ
Product Code Name
Implant, Eye Sphere
Public Device Record Key
52433d4f-cf3a-4347-9078-2589e496d332
Public Version Date
March 30, 2021
Public Version Number
4
DI Record Publish Date
October 16, 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 | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |