I9011S

GUDID 00844369016858

Push Injector, titanium

Lenstec Barbados Inc

Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable
Primary Device ID00844369016858
NIH Device Record Key048ab541-1b04-4af1-9995-0409b22286d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameI9011S
Version Model Number05-2135
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100844369016858 [Primary]

FDA Product Code

MSSFolders And Injectors, Intraocular Lens (Iol)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


[00844369016858]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-14
Device Publish Date2024-05-06

Devices Manufactured by Lenstec Barbados Inc

00844369016858 - I9011S2024-05-14Push Injector, titanium
00844369016858 - I9011S2024-05-14 Push Injector, titanium
00844369016865 - I90122024-05-14 Threaded Injector, Course Thread, Large Knob, Titanium
00844369016872 - I9012FS2024-05-14 Threaded (Slow) Injector, Fine Thread, Small Knob, Titanium
00844369018944 - LC162024-05-14 Box of 10 1.6mm LC16 injector cartridges
00844369018968 - LC242024-05-14 Box of 10 2.4mm LC24 injector cartridges
00844369018975 - CART45S2024-05-14 Box of 10 1.6mm CART45S injector cartridges
00844369018982 - CARTM2024-05-14 Box of 10 1.6mm CARTM injector cartridges
00844369002172 - SOFTEC HD PLI2018-07-06 IOL - HEMA 6.0/13mm (Pre-loaded)

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