SOFTEC HD PLI SOFTEC HD PLI

GUDID 00844369002462

IOL - HEMA 6.0/13mm (Pre-loaded)

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 ID00844369002462
NIH Device Record Key932c36d4-224b-4b8f-b3b3-b0625bec9054
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFTEC HD PLI
Version Model NumberSOFHDPLI+18.75D and PLITIP1645 Kit
Catalog NumberSOFTEC HD PLI
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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Device Size Text, specify0
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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
GS100844369002462 [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 HD PLI]

00844369002875IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002868IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002851IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002844IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002837IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002820IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002813IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002806IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002790IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002783IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002776IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002769IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002752IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002745IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002738IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002721IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002714IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002707IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002691IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002684IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002677IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002660IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002653IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002646IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002639IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002622IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002615IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002608IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002592IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002585IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002578IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002561IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002554IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002547IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002530IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002523IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002516IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002509IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002493IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002486IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002479IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002462IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002455IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002448IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002431IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002424IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002417IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002400IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002394IOL - HEMA 6.0/13mm (Pre-loaded)
00844369002387IOL - HEMA 6.0/13mm (Pre-loaded)

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