Silicone Tire 7mm

GUDID 10871321001840

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable
Primary Device ID10871321001840
NIH Device Record Key3dd2a607-abec-4649-a13e-0571acd8de86
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Tire 7mm
Version Model NumberS 3014
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
GS100871321000709 [Unit of Use]
GS110871321001840 [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 7mm]

18713210001840S 3014
18713210001642S 2986
10871321001840S 3014
10871321001642S 2986

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