Silicone Spheres (16 mm, 2.1 cc)

GUDID 10697660000197

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 ID: 10697660000197
• NIH Device Record Key: fd2682c5-281c-4aed-8d04-5a77b2ecfe99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Spheres (16 mm, 2.1 cc)
• Version Model Number: 11-216
• 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

• 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
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10697660000197 [Primary]
HIBCC	M8721121605 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112176

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

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

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10697660000197]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-10-17

On-Brand Devices [Silicone Spheres (16 mm, 2.1 cc)]

• 10697660000197: Silicone spheres are permanent implants used to replace the lost volume and to give motility to
• M8721121605: Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give