HEALON 5 10290051

GUDID 00385445083215

HEALON 5 23 MG/ML 0.60 ML US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative
Primary Device ID00385445083215
NIH Device Record Key78241ff0-84a8-49b6-b4fb-fc0fabef5e2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALON 5
Version Model Number10290051
Catalog Number10290051
Company DUNS103021940
Company NameJOHNSON & JOHNSON SURGICAL VISION, INC.
Device Count1
DM Exempttrue
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

Operating and Storage Conditions

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
GS100385445083215 [Primary]

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 Number4
Public Version Date2020-02-26
Device Publish Date2014-10-16

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

Trademark Results [HEALON 5]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEALON 5
HEALON 5
75766308 2716012 Live/Registered
AMO UPPSALA AB
1999-08-02

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