Acrylic Spheres 18 mm, 2.8 cc

GUDID M8721131808

Acrylic 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 users must gas sterilize (EtO) the acrylic spheres (not autoclave). The ophthalmic surgeon chooses the size and the type of implant for the surgery.

Oculo-Plastik Inc

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Primary Device IDM8721131808
NIH Device Record Key1c412496-0ada-4599-a155-3f66a1f16d72
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcrylic Spheres 18 mm, 2.8 cc
Version Model Number11-318
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

Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter
Total Volume2.8 Milliliter
Outer Diameter18 Millimeter
Outer Diameter18 Millimeter
Total Volume2.8 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS110697660000340 [Primary]
HIBCCM8721131808 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HPZImplant, Eye Sphere

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

[M8721131808]

Hydrogen Peroxide;Ethylene Oxide

[M8721131808]

Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-23
Device Publish Date2019-10-15

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