HEINE MPACK COMPLETE

GUDID B099X007996720

HEINE MPACK COMPLETE WITH TRANSFORMER

SONTEC INSTRUMENTS, INC.

Indirect binocular ophthalmoscope, battery-powered
Primary Device IDB099X007996720
NIH Device Record Keyb5d7198a-c11a-4c1f-afe0-4bea721a765a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEINE MPACK COMPLETE
Version Model NumberX-007.99.672
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 Batchfalse
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

Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM
Phone8008217496
EmailINFO@SONTECINSTRUMENTS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896009585 [Primary]
HIBCCB099X007996720 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLJOphthalmoscope, Battery-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B099X007996720]

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[B099X007996720]

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[B099X007996720]

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[B099X007996720]

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[B099X007996720]

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[B099X007996720]

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[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


[B099X007996720]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-24

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