Silicone Spheres (15 mm, 1.8 cc)

GUDID M8721121504

Silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.

Oculo-Plastik Inc

Orbital sphere implant
Primary Device IDM8721121504
NIH Device Record Key034d30c4-d2c5-44f2-8f87-ba3a35b8b934
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Spheres (15 mm, 1.8 cc)
Version Model Number11-215
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 Datefalse
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

Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Total Volume1.8 Milliliter
Total Volume1.8 Milliliter
Outer Diameter15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110697660000173 [Primary]
HIBCCM8721121504 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HPZImplant, Eye Sphere

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

[M8721121504]

Moist Heat or Steam Sterilization;Ethylene Oxide

[M8721121504]

Moist Heat or Steam Sterilization

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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