Grooved Sponge

GUDID 18713210001369

Labtician Ophthalmics, Inc

Scleral buckling device, bioabsorbable
Primary Device ID18713210001369
NIH Device Record Keye8c5e0da-5233-4a71-a0d5-4b96896c9837
Commercial Distribution StatusIn Commercial Distribution
Brand NameGrooved Sponge
Version Model NumberS 1983-3.2
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100871321000204 [Unit of Use]
GS108713210000204 [Unit of Use]
GS118713210001369 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-05

On-Brand Devices [Grooved Sponge]

18713210001406S 1983-7.5
18713210001390S 1983-3
18713210001383S 1983-4
18713210001376S 1983-3.5
18713210001369S 1983-3.2
18713210001352S 1983-3
18713210001321S 1983-2.3
10871321001406S 1983-7.5
10871321001390S 1983-3
10871321001383S 1983-4
10871321001376S 1983-3.5
10871321001352S 1983-3
10871321001321S 1983-2.3
10871321001369S 1983-3.2

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