HEINE MPACK LL BATTERY PACK

GUDID B099X007996610

HEINE MPACK LL BATTERY PACK

SONTEC INSTRUMENTS, INC.

Indirect binocular ophthalmoscope, battery-powered
Primary Device IDB099X007996610
NIH Device Record Keyd5b9d0e8-385e-4a94-9f30-d694e3ac2049
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEINE MPACK LL BATTERY PACK
Version Model NumberX-007.99.661
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
GS100192896009530 [Primary]
HIBCCB099X007996610 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLJOphthalmoscope, Battery-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

Dry Heat Sterilization


[B099X007996610]

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

Devices Manufactured by SONTEC INSTRUMENTS, INC.

00192896113725 - Easy Change Irrigation Aspiration System Tip2025-02-19 Easy Change Irrigation Aspiration System Straight Visco Removal Tip Titanium
00192896113732 - Easy Change Irrigation Aspiration System Tip2025-02-19 Easy Change Irrigation Aspiration System Curved Visco Removal Tip Titanium
00192896121089 - Debakey Scissors2025-02-14 Debakey Scissors 45° Angle
00192896121096 - Heartline Scalpel Blade Holder2025-02-14 Heartline Scalpel Blade Holder Round Handle Angled Titanium
00192896121102 - Small Blade Pair for Debakey Retractor2025-02-14 Small Blade Pair for Debakey Retractor Child Size
00192896121119 - Medium Blade Pair for Debakey Retractor2025-02-14 Medium Blade Pair for Debakey Retractor Child Size
00192896121126 - Large Blade Pair for Debakey Retractor2025-02-14 Large Blade Pair for Debakey Retractor Child Size
00192896121133 - Purse String Clamp2025-02-14 Purse String Clamp 42 Millimeter Jaw

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