ESCHENBACH LOUPE 17-1111

GUDID 00192896019324

ESCHENBACH LOUPE

SONTEC INSTRUMENTS, INC.

Direct ophthalmoscope, battery-powered
Primary Device ID00192896019324
NIH Device Record Key1405e2a5-6b7e-46ab-abb4-a28680f34776
Commercial Distribution StatusIn Commercial Distribution
Brand NameESCHENBACH LOUPE
Version Model Number17-1111
Catalog Number17-1111
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
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com
Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896019324 [Primary]

FDA Product Code

HJHLoupe, binocular, low power

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896019324]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-18
Device Publish Date2018-09-17

Devices Manufactured by SONTEC INSTRUMENTS, INC.

00192896098558 - Mayo Dissecting Scissors2025-04-01 Mayo Dissecting Scissors Beveled Blades Curved Quantum
00192896121348 - Mallet2025-04-01 Mallet Heavy
00192896121355 - Takahashi Suction Forceps2025-04-01 Takahashi Suction Forceps Straight Size 1 (3.5 Millimeter)
00192896121294 - Uterine Curette2025-03-25 Uterine Curette Double Ended Sharp/Blunt
00192896121300 - Mayo Dissecting Scissors2025-03-25 Mayo Dissecting Scissors Classic Beveled Blades Curved Left
00192896121317 - Semken Tissue Forceps2025-03-25 Semken Tissue Forceps With Tungsten Carbide Serrated Platform 1x2 Teeth
00192896121324 - Derf Needle Holder2025-03-25 Derf Needle Holder Miniature Tungsten Carbide Serrated Tip Quantum
00192896121331 - McPherson-Westcott Conjunctival Scissors2025-03-25 McPherson-Westcott Conjunctival Scissors Small Curved Blunt Blades Quantum

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