Molteno D1
GUDID 09419196000014
D1 Pressure Ridge Single Plate Molteno Implant - Sterile
MOLTENO OPHTHALMIC LIMITED
Glaucoma shunt| Primary Device ID | 09419196000014 |
| NIH Device Record Key | 3d83aeca-da50-4f82-b2ac-888df96082ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Molteno |
| Version Model Number | D1 |
| Catalog Number | D1 |
| 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 |
| 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 | |
| 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 |
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 |
| 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 | 09419196000014 [Primary] |
FDA Product Code
| KYF | Implant, Eye Valve |
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 | 2021-08-24 |
| Device Publish Date | 2016-08-12 |
On-Brand Devices [Molteno]
| 09419196000083 | P1 Paediatric/Microphthalmic 8mm Molteno Implant - Sterile |
| 09419196000076 | S1 Single Plate Molteno Implant - Sterile |
| 09419196000069 | R2 Right Eye, Double Plate Molteno Implant - Sterile |
| 09419196000052 | L2 Left Eye, Double Plate Molteno Implant - Sterile |
| 09419196000038 | DR2 Right Eye, Pressure Ridge, Double Plate Molteno Implant - Sterile |
| 09419196000021 | DL2 Left Eye, Pressure Ridge, Double Plate Molteno Implant - Sterile |
| 09419196000014 | D1 Pressure Ridge Single Plate Molteno Implant - Sterile |
Trademark Results [Molteno]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOLTENO 74450043 1850629 Live/Registered |
Molteno, Anthony Christopher Bernard 1993-10-22 |
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