HEALON PRO 10340012

GUDID 05050474807440

HEALON PRO 0,85 ML US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitreous/aqueous humour replacement medium, intraoperative
Primary Device ID05050474807440
NIH Device Record Keyd4c64c69-ba5b-4e26-8aa6-7a36a36b2a33
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALON PRO
Version Model Number10340012
Catalog Number10340012
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474807440 [Primary]

FDA Product Code

LZPAID, SURGICAL, VISCOELASTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-16
Device Publish Date2024-04-08

On-Brand Devices [HEALON PRO]

05050474636989HEALON PRO 0.85 ML US
05050474636972HEALON PRO 0.55 ML US
05050474807440HEALON PRO 0,85 ML US
05050474807433HEALON PRO 0,55 ML US

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