Durette #4, PMMA (20 mm, 3.5 cc) - The Durette® ocular implant, made of clear - Oculo-Plastik Inc

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

HPZ

Product Code Name

Implant, Eye Sphere

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCULO-PLASTIK INC" Characteristics
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