HEINE OMEGA 180 C-004.33.226

GUDID 00192896009486

HEINE - OMEGA 180 WITH EN15 AND TRANSFORMER

SONTEC INSTRUMENTS, INC.

Indirect binocular ophthalmoscope, line-powered
Primary Device ID00192896009486
NIH Device Record Key82996deb-781b-4451-9885-66fd7cd80834
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEINE OMEGA 180
Version Model NumberC-004.33.226
Catalog NumberC-004.33.226
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896009486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJILens, Fundus, Hruby, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009486]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-17
Device Publish Date2018-08-15

On-Brand Devices [HEINE OMEGA 180]

00192896009493HEINE - OMEGA 500 UNPLUGGED WITH HC50 L HEADBAND
00192896009486HEINE - OMEGA 180 WITH EN15 AND TRANSFORMER

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.