2.5mm Grooved Strip

GUDID 10871321001710

2.5mm Grooved Strip

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 ID10871321001710
NIH Device Record Key032bf780-646c-4143-804e-ec6abe2b5b52
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.5mm Grooved Strip
Version Model NumberS 2992-M
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
GS100871321000570 [Unit of Use]
GS110871321001710 [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 Number5
Public Version Date2021-01-28
Device Publish Date2018-02-22

On-Brand Devices [2.5mm Grooved Strip]

187132100017102.5mm Grooved Strip
108713210017102.5mm Grooved Strip

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