GENISI LASIK SPECULUM T10-1737

GUDID 00192896088214

GENISI LASIK SPECULUM SOLID BLADES ANGLED SHAFT TITANIUM

SONTEC INSTRUMENTS, INC.

Eyelid speculum, reusable
Primary Device ID00192896088214
NIH Device Record Key1070b067-a390-4c6a-969a-24e8329c273a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENISI LASIK SPECULUM
Version Model NumberT10-1737
Catalog NumberT10-1737
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length65 Millimeter
Length65 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896088214 [Primary]

FDA Product Code

HNCSpecula, ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896088214]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-09
Device Publish Date2018-09-12

Devices Manufactured by SONTEC INSTRUMENTS, INC.

00192896121003 - Kerrison Rongeur2025-01-14 Kerrison Rongeur With Ejector Pin Silicone Handle Internal Spring 14 Millimeter Opening 40 Degree Forward Thin Footplate
00192896121010 - Ferris-Smith Rongeur2025-01-14 Ferris-Smith Rongeur Take Apart With Internal Spring Straight 3 Millimeter x 10 Millimeter
00192896121027 - Ferris-Smith Rongeur2025-01-14 Ferris-Smith Rongeur Take Apart With Internal Spring Straight 4 Millimeter x 13 Millimeter
00192896121034 - Lemmon Sternal Spreader2025-01-14 Lemmon Sternal Spreader Serrated
00192896120952 - Metzenbaum Scissors2024-12-31 Metzenbaum Scissors Classic Curved Blade Fine
00192896120969 - Derf Needle Holder2024-12-31 Derf Needle Holder Tungsten Carbide Serrated Titanium
00192896120792 - Classic Dental Elevator Set2024-11-25 Classic Dental Elevator Set With Tray (8 Each)
00192896120808 - Dental Set2024-11-25 Dental Burnisher/Curette/Probe/Scaler Set Without Tray (13 Each)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.