SOFTEC HDM SOFTEC HDM

GUDID 00844369039611

IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)

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 ID00844369039611
NIH Device Record Keyf8c5fa2e-f118-463a-a46f-eb3951850509
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFTEC HDM
Version Model NumberSOFTECHDM+31.0
Catalog NumberSOFTEC HDM
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
GS100844369039611 [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 Date2016-09-23

On-Brand Devices [SOFTEC HDM]

00844369039727IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039710IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039703IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039697IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039680IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039666IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039659IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039642IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039635IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039628IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039611IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039604IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039598IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039581IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039574IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039567IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039550IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039543IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039536IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039529IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039512IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039505IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039499IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039482IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039475IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039468IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039451IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039444IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039437IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039420IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039413IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039406IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039390IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039383IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039376IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039369IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039352IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039345IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039338IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039321IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039314IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039307IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039291IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039284IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039277IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039260IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039253IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039246IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039239IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)
00844369039222IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision)

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