HEALON GV PRO 10240014

GUDID 05050474651654

HEALON GV PRO 0.85ML US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative
Primary Device ID05050474651654
NIH Device Record Key766d7932-2560-48a5-8a4a-1f0ca19d89bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALON GV PRO
Version Model Number10240014
Catalog Number10240014
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 Batchtrue
Serial Numberfalse
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
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474651654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZPAID, SURGICAL, VISCOELASTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-26
Device Publish Date2019-05-15

Devices Manufactured by JOHNSON & JOHNSON SURGICAL VISION, INC.

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
05050474811072 - TECNIS ODYSSEY TORIC II IOL2024-01-29 TEC ODYSSEY TOR II SMPCY 06.0D CYL1.50
05050474811089 - TECNIS ODYSSEY TORIC II IOL2024-01-29 TEC ODYSSEY TOR II SMPCY 06.5D CYL1.50
05050474811096 - TECNIS ODYSSEY TORIC II IOL2024-01-29 TEC ODYSSEY TOR II SMPCY 07.0D CYL1.50
05050474811102 - TECNIS ODYSSEY TORIC II IOL2024-01-29 TEC ODYSSEY TOR II SMPCY 07.5D CYL1.50

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