Duns Number:257382580
Device Description: The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface mo The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Catalog Number
-
Brand Name
Durette #4, PMMA (20 mm, 3.5 cc)
Version/Model Number
12-420
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2020
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
09cb71f0-8ed2-4b4a-b5c5-4487be3b46e4
Public Version Date
March 30, 2021
Public Version Number
2
DI Record Publish Date
October 17, 2019
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 |