BAERVELDT PARS PLANA GLAUCOMA IMPLANT 23030818

GUDID 05050474513006

GLAUCOMA IMPLANT BG102-350 GLOBAL

JOHNSON & JOHNSON SURGICAL VISION, INC.

Glaucoma shunt
Primary Device ID05050474513006
NIH Device Record Keyd9ba94cf-f544-46d6-8a67-4a06c12ef5e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBAERVELDT PARS PLANA GLAUCOMA IMPLANT
Version Model NumberBG102350
Catalog Number23030818
Company DUNS103021940
Company NameJOHNSON & JOHNSON SURGICAL VISION, INC.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM
Phone+1(877)266-4543
EmailJJV-US-SURGICALORDERS@ITS.JNJ.COM

Device Dimensions

Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter
Area/Surface Area350 Square millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474513006 [Primary]

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 Date2020-02-26
Device Publish Date2015-09-15

Devices Manufactured by JOHNSON & JOHNSON SURGICAL VISION, INC.

05050474807433 - HEALON PRO2024-04-16 HEALON PRO 0,55 ML US
05050474807440 - HEALON PRO2024-04-16 HEALON PRO 0,85 ML US
05050474807457 - HEALON GV PRO2024-04-16 HEALON GV PRO 0,85 ML US
05050474807464 - HEALON5 PRO2024-04-16 HEALON5 PRO 0,6 ML US
05050474812765 - TECNIS ODYSSEY TORIC II IOL2024-02-01 TEC ODYSSEY TOR II SMPCY 31.5D CYL3.00
05050474812888 - TECNIS ODYSSEY TORIC II IOL2024-02-01 TEC ODYSSEY TOR II SMPCY 08.0D CYL3.75
05050474811058 - TECNIS ODYSSEY TORIC II IOL2024-01-29 TEC ODYSSEY TOR II SMPCY 05.0D CYL1.50
05050474811065 - TECNIS ODYSSEY TORIC II IOL2024-01-29 TEC ODYSSEY TOR II SMPCY 05.5D CYL1.50

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.