ONE SERIES ULTRA 1VIPR30

GUDID 15050474534602

ONE SERIES ULTRA CARTRIDGE 30/BOX

JOHNSON & JOHNSON SURGICAL VISION, INC.

Intraocular lens-insertion cartridge
Primary Device ID15050474534602
NIH Device Record Keyecf75317-5a3a-43fb-8c5a-261b3fd1eac3
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE SERIES ULTRA
Version Model Number1VIPR30
Catalog Number1VIPR30
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105050474534605 [Primary]
GS115050474534602 [Package]
Contains: 05050474534605
Package: Box [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KYBLENS, GUIDE, INTRAOCULAR

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 Date2019-02-13

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