SOFTEC I SOFTEC I

GUDID 00844369029117

IOL - HEMA - 1pc 5.75/12.0mm

Lenstec Barbados 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 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 ID00844369029117
NIH Device Record Keydc635b25-264f-4c24-83f0-a2ced2b56b25
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFTEC I
Version Model NumberSOFTECI+5.0
Catalog NumberSOFTEC I
Company DUNS860235001
Company NameLenstec Barbados 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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com
Phone1-866-536-7832
Emailfeedback@lenstec.com

Device Dimensions

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Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844369029117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQLIntraocular Lens

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-01

On-Brand Devices [SOFTEC I]

00844369029933IOL - HEMA - 1pc 5.75/12.0mm
00844369029926IOL - HEMA - 1pc 5.75/12.0mm
00844369029919IOL - HEMA - 1pc 5.75/12.0mm
00844369029902IOL - HEMA - 1pc 5.75/12.0mm
00844369029896IOL - HEMA - 1pc 5.75/12.0mm
00844369029889IOL - HEMA - 1pc 5.75/12.0mm
00844369029872IOL - HEMA - 1pc 5.75/12.0mm
00844369029865IOL - HEMA - 1pc 5.75/12.0mm
00844369029858IOL - HEMA - 1pc 5.75/12.0mm
00844369029841IOL - HEMA - 1pc 5.75/12.0mm
00844369029827IOL - HEMA - 1pc 5.75/12.0mm
00844369029810IOL - HEMA - 1pc 5.75/12.0mm
00844369029803IOL - HEMA - 1pc 5.75/12.0mm
00844369029797IOL - HEMA - 1pc 5.75/12.0mm
00844369029780IOL - HEMA - 1pc 5.75/12.0mm
00844369029773IOL - HEMA - 1pc 5.75/12.0mm
00844369029766IOL - HEMA - 1pc 5.75/12.0mm
00844369029759IOL - HEMA - 1pc 5.75/12.0mm
00844369029742IOL - HEMA - 1pc 5.75/12.0mm
00844369029735IOL - HEMA - 1pc 5.75/12.0mm
00844369029728IOL - HEMA - 1pc 5.75/12.0mm
00844369029711IOL - HEMA - 1pc 5.75/12.0mm
00844369029704IOL - HEMA - 1pc 5.75/12.0mm
00844369029698IOL - HEMA - 1pc 5.75/12.0mm
00844369029681IOL - HEMA - 1pc 5.75/12.0mm
00844369029674IOL - HEMA - 1pc 5.75/12.0mm
00844369029667IOL - HEMA - 1pc 5.75/12.0mm
00844369029650IOL - HEMA - 1pc 5.75/12.0mm
00844369029643IOL - HEMA - 1pc 5.75/12.0mm
00844369029636IOL - HEMA - 1pc 5.75/12.0mm
00844369029629IOL - HEMA - 1pc 5.75/12.0mm
00844369029612IOL - HEMA - 1pc 5.75/12.0mm
00844369029605IOL - HEMA - 1pc 5.75/12.0mm
00844369029599IOL - HEMA - 1pc 5.75/12.0mm
00844369029582IOL - HEMA - 1pc 5.75/12.0mm
00844369029575IOL - HEMA - 1pc 5.75/12.0mm
00844369029568IOL - HEMA - 1pc 5.75/12.0mm
00844369029551IOL - HEMA - 1pc 5.75/12.0mm
00844369029544IOL - HEMA - 1pc 5.75/12.0mm
00844369029537IOL - HEMA - 1pc 5.75/12.0mm
00844369029520IOL - HEMA - 1pc 5.75/12.0mm
00844369029513IOL - HEMA - 1pc 5.75/12.0mm
00844369029506IOL - HEMA - 1pc 5.75/12.0mm
00844369029490IOL - HEMA - 1pc 5.75/12.0mm
00844369029483IOL - HEMA - 1pc 5.75/12.0mm
00844369029476IOL - HEMA - 1pc 5.75/12.0mm
00844369029469IOL - HEMA - 1pc 5.75/12.0mm
00844369029452IOL - HEMA - 1pc 5.75/12.0mm
00844369029445IOL - HEMA - 1pc 5.75/12.0mm
00844369029438IOL - HEMA - 1pc 5.75/12.0mm

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