Grooved Part Thickness Sponge

GUDID 10871321001338

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable
Primary Device ID10871321001338
NIH Device Record Keya5fb6a20-e3ad-4561-9f2b-aa38f422a884
Commercial Distribution StatusIn Commercial Distribution
Brand NameGrooved Part Thickness Sponge
Version Model NumberS 1983-2.5
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
GS100871321000174 [Unit of Use]
GS110871321001338 [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 Date2015-10-05

On-Brand Devices [Grooved Part Thickness Sponge]

18713210001345S 1983-2.8
18713210001338S 1983-2.5
10871321001345S 1983-2.8
10871321001338S 1983-2.5

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