Silicone Tire 10mm

GUDID 10871321001628

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 ID10871321001628
NIH Device Record Key70dd17f0-f853-46e7-8d3b-8d2f9cecbbf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Tire 10mm
Version Model NumberS 2977
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
GS100871321000488 [Unit of Use]
GS110871321001628 [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 10mm]

18713210001864S 3016
18713210001758S 2996
18713210001628S 2977
10871321001864S 3016
10871321001758S 2996
10871321001628S 2977

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