Molteno P1
GUDID 09419196000083
P1 Paediatric/Microphthalmic 8mm Molteno Implant - Sterile
MOLTENO OPHTHALMIC LIMITED
Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt Glaucoma shunt| Primary Device ID | 09419196000083 |
| NIH Device Record Key | 9bf2f22c-d202-4d58-803f-a493a1bb4e25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Molteno |
| Version Model Number | P1 |
| Catalog Number | P1 |
| 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 |
Device Dimensions
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 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 |
| 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 | 09419196000083 [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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