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.

00192896113725 - Easy Change Irrigation Aspiration System Tip2025-02-19 Easy Change Irrigation Aspiration System Straight Visco Removal Tip Titanium
00192896113732 - Easy Change Irrigation Aspiration System Tip2025-02-19 Easy Change Irrigation Aspiration System Curved Visco Removal Tip Titanium
00192896121089 - Debakey Scissors2025-02-14 Debakey Scissors 45° Angle
00192896121096 - Heartline Scalpel Blade Holder2025-02-14 Heartline Scalpel Blade Holder Round Handle Angled Titanium
00192896121102 - Small Blade Pair for Debakey Retractor2025-02-14 Small Blade Pair for Debakey Retractor Child Size
00192896121119 - Medium Blade Pair for Debakey Retractor2025-02-14 Medium Blade Pair for Debakey Retractor Child Size
00192896121126 - Large Blade Pair for Debakey Retractor2025-02-14 Large Blade Pair for Debakey Retractor Child Size
00192896121133 - Purse String Clamp2025-02-14 Purse String Clamp 42 Millimeter Jaw

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