HEALON DUET PRO 10240016

GUDID 05050474651425

HEALON DUET PRO 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
Primary Device ID05050474651425
NIH Device Record Keybd912908-a49c-43be-b9f2-21ffd2c3216c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALON DUET PRO
Version Model Number10240016
Catalog Number10240016
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474651425 [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 Number3
Public Version Date2020-02-26
Device Publish Date2018-07-16

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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

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