Silicone Tire 12.5mm

GUDID 10871321001772

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 ID10871321001772
NIH Device Record Keyeec7e8d0-4f26-482f-99a6-8c67c874fe3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Tire 12.5mm
Version Model NumberS 2997
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
GS100871321000631 [Unit of Use]
GS110871321001772 [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 [Silicone Tire 12.5mm]

18713210001772S 2997
10871321001772S 2997

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