FDA.reportPublic FDA data

EX-PRESS®

Primary DI
00380650704948
Brand
EX-PRESS®
Company
Alcon Laboratories, Inc.
Model
P-200
Device description
EX-PRESS® Glaucoma Filtration Device - Version P-200
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
00380650704948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380650704948003806507049483806507049480380650704948

GMDN Terms#

Term, Definition table
TermDefinition
Glaucoma shuntA sterile, 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter200Micrometer

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 241-5999web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

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
09419196000069MoltenoMOLTENO 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
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