FDA.reportPublic FDA data

Molteno

Primary DI
09419196000069
Brand
Molteno
Company
MOLTENO OPHTHALMIC LIMITED
Model
R2
Catalog number
R2
Device description
R2 Right Eye, Double Plate Molteno Implant - Sterile
Published
2016-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYFImplant, Eye Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYFImplant, Eye ValveOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09419196000069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09419196000069094191960000699419196000069

GMDN Terms#

Term, Definition table
TermDefinition
Glaucoma shuntA non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6434792744info@molteno.com

Regulatory Flags#

DUNS number
760385075
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09419196000014MoltenoD1D12016-08-12
09419196000021MoltenoDL2DL22016-08-12
09419196000038MoltenoDR2DR22016-08-12
09419196000052MoltenoL2L22016-08-12
09419196000076MoltenoS1S12016-08-12
09419196000083MoltenoP1P12016-08-12
09419196000090Molteno3GS-175GS-1752016-08-12
09419196000106Molteno3GL-230GL-2302016-08-12
09419196000212Molteno3SS-185SS-1852016-08-12
09419196000229Molteno3SL-245SL-2452016-08-12
09419196000168Molteno M-SphereMS16MS162016-08-12
09419196000175Molteno M-SphereMS18MS182016-08-12
09419196000182Molteno M-SphereMS20MS202016-08-12
09419196000199Molteno M-SphereMS22MS222016-08-12
09419196000205Molteno MoaBoneMS08MS082016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380650500045EX-PRESSAlcon Laboratories, Inc.KYF2025-09-23
00892064002089Ahmed ClearPath STNEW WORLD MEDICAL, INCORPORATEDKYF2024-12-18
00892064002096Ahmed ClearPath STNEW WORLD MEDICAL, INCORPORATEDKYF2024-12-18
00853704002449iStent InfiniteGLAUKOS CORPORATIONKYF2022-10-19
00853704002470iStent infiniteGLAUKOS CORPORATIONKYF2022-10-05
00892064002188Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2020-08-12
00892064002348Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATEDKYF2019-01-23
00892064002355Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATEDKYF2019-01-23
10888628032439XEN Glaucoma Treatment SystemAllergan, Inc.KYF2018-01-30
00892064002126Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2017-09-08
00892064002119Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2016-11-16
09419196000014MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000021MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000038MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000052MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000076MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000083MoltenoMOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000090Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000106Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000212Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
09419196000229Molteno3MOLTENO OPHTHALMIC LIMITEDKYF2016-08-12
00380650704931EX-PRESS®Alcon Laboratories, Inc.KYF2015-10-24
00380650704948EX-PRESS®Alcon Laboratories, Inc.KYF2015-10-24
05050474512993BAERVELDT GLAUCOMA IMPLANT (350)JOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
05050474513006BAERVELDT PARS PLANA GLAUCOMA IMPLANTJOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
05050474513013BAERVELDT GLAUCOMA IMPLANT (250)JOHNSON & JOHNSON SURGICAL VISION, INC.KYF2015-09-15
00892064002140Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24
00892064002270Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24
00892064002133Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDKYF2015-03-24