HEINE - MPACK PLUG-IN TRANSFORMER X-095.16.315

GUDID 00192896009615

HEINE - MPACK PLUG-IN TRANSFORMER

SONTEC INSTRUMENTS, INC.

Indirect binocular ophthalmoscope, battery-powered
Primary Device ID00192896009615
NIH Device Record Keyf7c44ad2-b628-40d0-af62-a229714b8779
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEINE - MPACK PLUG-IN TRANSFORMER
Version Model NumberX-095.16.315
Catalog NumberX-095.16.315
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896009615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLJOphthalmoscope, Battery-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[00192896009615]

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

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