Partial Thickness Sponge

GUDID 10871321001420

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable
Primary Device ID10871321001420
NIH Device Record Key787c4d3b-41d6-4a60-938e-b6839754461b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePartial Thickness Sponge
Version Model NumberS 1984-3
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
Phone905-829-0055
Emailphilcuscuna@labtician.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100871321000266 [Unit of Use]
GS110871321001420 [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 Date2021-01-27
Device Publish Date2015-10-09

On-Brand Devices [Partial Thickness Sponge]

18713210001451S 1984-7.5
18713210001444S 1984-5
18713210001437S 1984-3.3
18713210001420S 1984-3
18713210001413S 1984-2.5
10871321001451S 1984-7.5
10871321001444S 1984-5
10871321001437S 1984-3.3
10871321001420S 1984-3
10871321001413S 1984-2.5

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