| Primary Device ID | 09419196000205 |
| NIH Device Record Key | ced4e0ff-aaad-4020-ac04-fecbdc83e9f0 |
| Commercial Distribution Discontinuation | 2023-06-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Molteno MoaBone |
| Version Model Number | MS08 |
| Catalog Number | MS08 |
| 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 |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com | |
| Phone | +6434792744 |
| info@molteno.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 09419196000205 [Primary] |
| HPZ | Implant, Eye Sphere |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-15 |
| Device Publish Date | 2016-08-12 |
| 09419196000168 - Molteno M-Sphere | 2023-06-15 MS16 - Molteno M-Sphere® 16mm Natural Hydroxyapatite Orbital Implant |
| 09419196000175 - Molteno M-Sphere | 2023-06-15 MS18 - Molteno M-Sphere® 18mm Natural Hydroxyapatite Orbital Implant |
| 09419196000182 - Molteno M-Sphere | 2023-06-15 MS20 - Molteno M-Sphere® 20mm Natural Hydroxyapatite Orbital Implant |
| 09419196000199 - Molteno M-Sphere | 2023-06-15 MS22 - Molteno M-Sphere® 22mm Natural Hydroxyapatite Orbital Implant |
| 09419196000205 - Molteno MoaBone | 2023-06-15MS08 - MoaBone® Reconstruction pack (4 assorted segments) |
| 09419196000205 - Molteno MoaBone | 2023-06-15 MS08 - MoaBone® Reconstruction pack (4 assorted segments) |
| 09419196000014 - Molteno | 2021-08-24 D1 Pressure Ridge Single Plate Molteno Implant - Sterile |
| 09419196000021 - Molteno | 2021-08-24 DL2 Left Eye, Pressure Ridge, Double Plate Molteno Implant - Sterile |
| 09419196000038 - Molteno | 2021-08-24 DR2 Right Eye, Pressure Ridge, Double Plate Molteno Implant - Sterile |