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

Orbital sphere implant

• 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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

[10697660000333]

Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-10-15

On-Brand Devices [Acrylic Spheres 16 mm, 2.1 cc]

• 10697660000333: Acrylic spheres are permanent implants used to replace the lost volume and to give motility to t
• M8721131606: Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give