Durette #4, PMMA (20 mm, 3.5 cc)
Basic Information
- Brand Name
- Durette #4, PMMA (20 mm, 3.5 cc)
- Primary DI
- 10697660000418
- Version / Model
- 12-420
- Company Name
- Oculo-Plastik Inc
- Labeler DUNS
- 257382580
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-17
- Public Version
- 2
- Public Version Date
- 2021-03-30
- Public Version Status
- Update
- Public Device Record Key
- 09cb71f0-8ed2-4b4a-b5c5-4487be3b46e4
- Distribution End Date
- 2020-09-01
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HPZ | Implant, Eye Sphere | Ophthalmic | 886.3320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46902 | Orbital sphere implant | An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | M8721242003 | HIBCC | ||||
| Primary | 10697660000418 | GS1 |
Customer Contacts
- Phone
- 514-381-3292
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 20 | Millimeter | |
| Total Volume | 3.5 | Milliliter |