TECNIS IOL ZXW375U220

GUDID 05050474738911

TECNIS SYMF TORIC II OB 22.0D CYL3.75 US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic
Primary Device ID05050474738911
NIH Device Record Key15a7b1d9-23fa-437c-ad7b-667a8e346707
Commercial Distribution StatusIn Commercial Distribution
Brand NameTECNIS IOL
Version Model NumberZXW375
Catalog NumberZXW375U220
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Dimensions

Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 Millimeter
Outer Diameter13 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

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474738911 [Primary]
GS105050474738911 [Primary]
GS105050474738911 [Primary]
GS105050474738911 [Primary]
GS105050474738911 [Primary]
GS105050474738911 [Primary]
GS105050474738911 [Primary]
GS105050474738911 [Primary]

FDA Product Code

POEExtended depth of focus intraocular lens
POEExtended depth of focus intraocular lens
POEExtended depth of focus intraocular lens
POEExtended depth of focus intraocular lens
POEExtended depth of focus intraocular lens
POEExtended depth of focus intraocular lens
POEExtended depth of focus intraocular lens
POEExtended depth of focus intraocular lens

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

On-Brand Devices [TECNIS IOL]

05050474607255TECNIS SYMFONY TORIC ERV 34.0D CYL3.75
05050474607248TECNIS SYMFONY TORIC ERV 33.5D CYL3.75
05050474607231TECNIS SYMFONY TORIC ERV 33.0D CYL3.75
05050474607224TECNIS SYMFONY TORIC ERV 32.5D CYL3.75
05050474607217TECNIS SYMFONY TORIC ERV 32.0D CYL3.75
05050474607200TECNIS SYMFONY TORIC ERV 31.5D CYL3.75
05050474607194TECNIS SYMFONY TORIC ERV 31.0D CYL3.75
05050474607187TECNIS SYMFONY TORIC ERV 30.5D CYL3.75
05050474607170TECNIS SYMFONY TORIC ERV 30.0D CYL3.75
05050474607163TECNIS SYMFONY TORIC ERV 29.5D CYL3.75
05050474607156TECNIS SYMFONY TORIC ERV 29.0D CYL3.75
05050474607149TECNIS SYMFONY TORIC ERV 28.5D CYL3.75
05050474607132TECNIS SYMFONY TORIC ERV 28.0D CYL3.75
05050474607125TECNIS SYMFONY TORIC ERV 27.5D CYL3.75
05050474607118TECNIS SYMFONY TORIC ERV 27.0D CYL3.75
05050474607101TECNIS SYMFONY TORIC ERV 26.5D CYL3.75
05050474607095TECNIS SYMFONY TORIC ERV 26.0D CYL3.75
05050474607088TECNIS SYMFONY TORIC ERV 25.5D CYL3.75
05050474607071TECNIS SYMFONY TORIC ERV 25.0D CYL3.75
05050474607064TECNIS SYMFONY TORIC ERV 24.5D CYL3.75
05050474607057TECNIS SYMFONY TORIC ERV 24.0D CYL3.75
05050474607040TECNIS SYMFONY TORIC ERV 23.5D CYL3.75
05050474607033TECNIS SYMFONY TORIC ERV 23.0D CYL3.75
05050474607026TECNIS SYMFONY TORIC ERV 22.5D CYL3.75
05050474607019TECNIS SYMFONY TORIC ERV 22.0D CYL3.75
05050474607002TECNIS SYMFONY TORIC ERV 21.5D CYL3.75
05050474606999TECNIS SYMFONY TORIC ERV 21.0D CYL3.75
05050474606982TECNIS SYMFONY TORIC ERV 20.5D CYL3.75
05050474606975TECNIS SYMFONY TORIC ERV 20.0D CYL3.75
05050474606968TECNIS SYMFONY TORIC ERV 19.5D CYL3.75
05050474606951TECNIS SYMFONY TORIC ERV 19.0D CYL3.75
05050474606944TECNIS SYMFONY TORIC ERV 18.5D CYL3.75
05050474606937TECNIS SYMFONY TORIC ERV 18.0D CYL3.75
05050474606920TECNIS SYMFONY TORIC ERV 17.5D CYL3.75
05050474606913TECNIS SYMFONY TORIC ERV 17.0D CYL3.75
05050474606906TECNIS SYMFONY TORIC ERV 16.5D CYL3.75
05050474606890TECNIS SYMFONY TORIC ERV 16.0D CYL3.75
05050474606883TECNIS SYMFONY TORIC ERV 15.5D CYL3.75
05050474606876TECNIS SYMFONY TORIC ERV 15.0D CYL3.75
05050474606869TECNIS SYMFONY TORIC ERV 14.5D CYL3.75
05050474606852TECNIS SYMFONY TORIC ERV 14.0D CYL3.75
05050474606845TECNIS SYMFONY TORIC ERV 13.5D CYL3.75
05050474606838TECNIS SYMFONY TORIC ERV 13.0D CYL3.75
05050474606821TECNIS SYMFONY TORIC ERV 12.5D CYL3.75
05050474606814TECNIS SYMFONY TORIC ERV 12.0D CYL3.75
05050474606807TECNIS SYMFONY TORIC ERV 11.5D CYL3.75
05050474606791TECNIS SYMFONY TORIC ERV 11.0D CYL3.75
05050474606784TECNIS SYMFONY TORIC ERV 10.5D CYL3.75
05050474606777TECNIS SYMFONY TORIC ERV 10.0D CYL3.75
05050474606760TECNIS SYMFONY TORIC ERV 09.5D CYL3.75

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.