IDESIGN RS 0110-3521

GUDID 05050474620278

PACK IN, IDESIGN, VISION TABLE UPGRADE

JOHNSON & JOHNSON SURGICAL VISION, INC.

Ophthalmic refractometer, manual Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer
Primary Device ID05050474620278
NIH Device Record Key4901806c-3081-42d5-93e1-64c1d64b3594
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDESIGN RS
Version Model NumberG301
Catalog Number0110-3521
Company DUNS010130626
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
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
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

Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474620278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZSExcimer laser system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-26
Device Publish Date2018-08-21

On-Brand Devices [IDESIGN RS]

05050474651456KIT, IDESIGN RS UPGRADE, US
05050474651449ASSY, CRATED, TABLE, VISION
05050474651432IDESIGN REFRACTIVE STUDIO ABERROMETER US
05050474620278PACK IN, IDESIGN, VISION TABLE UPGRADE

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