Acrylic Spheres 16 mm, 2.1 cc

GUDID 10697660000333

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 ID	10697660000333
NIH Device Record Key	fd97403b-e4fe-4d42-be68-f57105f96c42
Commercial Distribution Status	In Commercial Distribution
Brand Name	Acrylic Spheres 16 mm, 2.1 cc
Version Model Number	11-316
Company DUNS	257382580
Company Name	Oculo-Plastik Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com
Phone	514-381-3292
Email	sales@oculoplastik.com

Device Dimensions

Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter
Outer Diameter	16 Millimeter
Total Volume	2.1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10697660000333 [Primary]
HIBCC	M8721131606 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K040689

FDA Product Code

HPZ	Implant, Eye Sphere