FDA.reportPublic FDA data

BAERVELDT PARS PLANA GLAUCOMA IMPLANT

Primary DI
05050474513006
Brand
BAERVELDT PARS PLANA GLAUCOMA IMPLANT
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
BG102350
Catalog number
23030818
Device description
GLAUCOMA IMPLANT BG102-350 GLOBAL
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05050474513006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474513006050504745130065050474513006

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
Area/Surface Area350Square millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature045 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags#

DUNS number
103021940
Device count
1
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

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
00380650704948EX-PRESS®Alcon Laboratories, Inc.KYF2015-10-24
05050474512993BAERVELDT GLAUCOMA IMPLANT (350)JOHNSON & 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