BETA 4 USB LI-ION RECHARABLE HANDLE X-007.99.388

GUDID 00192896088559

BETA 4 USB LI-ION RECHARABLE HANDLE

SONTEC INSTRUMENTS, INC.

Indirect binocular ophthalmoscope, battery-powered
Primary Device ID00192896088559
NIH Device Record Keyf5a6018a-986a-4020-87fd-09e3270afb11
Commercial Distribution StatusIn Commercial Distribution
Brand NameBETA 4 USB LI-ION RECHARABLE HANDLE
Version Model NumberX-007.99.388
Catalog NumberX-007.99.388
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

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
GS100192896088559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLJOphthalmoscope, battery-powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

[00192896088559]

Dry Heat Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

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