Molteno3 GS-175

GUDID 09419196000090

Molteno3 GS (175mm2) Glaucoma Drainage Device

MOLTENO OPHTHALMIC LIMITED

Glaucoma shunt
Primary Device ID09419196000090
NIH Device Record Keyc6ebfa24-2254-45c7-a56b-8fd352eeaca2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMolteno3
Version Model NumberGS-175
Catalog NumberGS-175
Company DUNS760385075
Company NameMOLTENO OPHTHALMIC LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com
Phone+6434792744
Emailinfo@molteno.com

Device Dimensions

Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter
Area/Surface Area175 Square millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109419196000090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KYFImplant, Eye Valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-23
Device Publish Date2016-08-12

On-Brand Devices [Molteno3]

09419196000229Molteno3 SL (245mm2) Glaucoma Drainage Device
09419196000212Molteno3 SS (185mm2) Glaucoma Drainage Device
09419196000106Molteno3 GL (230mm2) Glaucoma Drainage Device
09419196000090Molteno3 GS (175mm2) Glaucoma Drainage Device

Trademark Results [Molteno3]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MOLTENO3
MOLTENO3
78682325 3277087 Dead/Cancelled
Molteno, Anthony Christopher Bernard
2005-07-31

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