Meridional Implant - Flat

GUDID 10871321001635

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable Scleral buckling device, bioabsorbable
Primary Device ID10871321001635
NIH Device Record Key09b1f6bc-56b2-4eb7-ac74-51ff7e343f79
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeridional Implant - Flat
Version Model NumberS 2978
Company DUNS248911026
Company NameLabtician Ophthalmics, Inc
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com
Phone905-829-0055
Emailphilcuscuna@labtician.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100871321000495 [Unit of Use]
GS110871321001635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQJImplant, Absorbable, (Scleral Buckling Methods)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-01-28
Device Publish Date2015-10-09

On-Brand Devices [Meridional Implant - Flat]

18713210001635S 2978
10871321001635S 2978

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.