Molteno3 GL-230
GUDID 09419196000106
Molteno3 GL (230mm2) Glaucoma Drainage Device
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 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 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 | 09419196000106 |
| NIH Device Record Key | b9fb3e06-6561-459a-b8c7-058d98799527 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Molteno3 |
| Version Model Number | GL-230 |
| Catalog Number | GL-230 |
| 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 | |
| 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 | |
| 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
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square millimeter |
| Area/Surface Area | 230 Square 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 |
| 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 |
| 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 | 09419196000106 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062252
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 | 4 |
| Public Version Date | 2020-12-23 |
| Device Publish Date | 2016-08-12 |
On-Brand Devices [Molteno3]
| 09419196000229 | Molteno3 SL (245mm2) Glaucoma Drainage Device |
| 09419196000212 | Molteno3 SS (185mm2) Glaucoma Drainage Device |
| 09419196000106 | Molteno3 GL (230mm2) Glaucoma Drainage Device |
| 09419196000090 | Molteno3 GS (175mm2) Glaucoma Drainage Device |
Trademark Results [Molteno3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOLTENO3 78682325 3277087 Dead/Cancelled |
Molteno, Anthony Christopher Bernard 2005-07-31 |
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