Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT

GUDID 10380657524362

23 GA TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator

Alcon Laboratories, Inc.

Vitrectomy system handpiece
Primary Device ID10380657524362
NIH Device Record Keyb154c909-d0fe-4bf5-9208-08df83f39d2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameConstellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT
Version Model Number8065752436
Company DUNS008018525
Company NameAlcon Laboratories, 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 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(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100380657524365 [Primary]
GS110380657524362 [Package]
Contains: 00380657524365
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLZVitrectomy, instrument cutter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-20
Device Publish Date2018-07-19

On-Brand Devices [Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT]

1038065752451525+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoillumina
1038065752450825+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminato
1038065752449223 GA TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoillumi
1038065752439327+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator
1038065752438625+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator
1038065752437925+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator
1038065752436223 GA TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator
1038065752435523 GA TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator

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