Molteno M-Sphere MS18

GUDID 09419196000175

MS18 - Molteno M-Sphere® 18mm Natural Hydroxyapatite Orbital Implant

MOLTENO OPHTHALMIC LIMITED

Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable Bone matrix implant, animal-derived, non-bioabsorbable

• Primary Device ID: 09419196000175
• NIH Device Record Key: 4c12dead-fca8-47af-a167-5a052d27079c
• Commercial Distribution Discontinuation: 2023-06-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Molteno M-Sphere
• Version Model Number: MS18
• Catalog Number: MS18
• Company DUNS: 760385075
• Company Name: MOLTENO OPHTHALMIC LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com
• Phone: +6434792744
• Email: info@molteno.com

Device Dimensions

• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09419196000175 [Primary]

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-06-15
• Device Publish Date: 2016-08-12

On-Brand Devices [Molteno M-Sphere]

• 09419196000199: MS22 - Molteno M-Sphere® 22mm Natural Hydroxyapatite Orbital Implant
• 09419196000182: MS20 - Molteno M-Sphere® 20mm Natural Hydroxyapatite Orbital Implant
• 09419196000175: MS18 - Molteno M-Sphere® 18mm Natural Hydroxyapatite Orbital Implant
• 09419196000168: MS16 - Molteno M-Sphere® 16mm Natural Hydroxyapatite Orbital Implant