Durette #4, PMMA (20 mm, 3.5 cc)

GUDID M8721242003

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.

Oculo-Plastik Inc

Orbital sphere implant
Primary Device IDM8721242003
NIH Device Record Key09cb71f0-8ed2-4b4a-b5c5-4487be3b46e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurette #4, PMMA (20 mm, 3.5 cc)
Version Model Number12-420
Company DUNS257382580
Company NameOculo-Plastik Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com
Phone514-381-3292
Emailsales@oculoplastik.com

Device Dimensions

Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Total Volume3.5 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS110697660000418 [Primary]
HIBCCM8721242003 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HPZImplant, Eye Sphere

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M8721242003]

Ethylene Oxide

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Ethylene Oxide

[M8721242003]

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[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

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Ethylene Oxide

[M8721242003]

Ethylene Oxide

[M8721242003]

Ethylene Oxide

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[M8721242003]

Ethylene Oxide

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Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-25
Device Publish Date2019-10-17

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