LOUPE LIGHT 2 C-008.32.265

GUDID 00192896092525

LOUPE LIGHT 2 WITH MPACK MINIATURE & PLUG IN TRANSFORMER

SONTEC INSTRUMENTS, INC.

Loupe
Primary Device ID00192896092525
NIH Device Record Key8c145f7a-2800-4253-ac64-329ac7fa33cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOUPE LIGHT 2
Version Model NumberC-008.32.265
Catalog NumberC-008.32.265
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896092525 [Primary]

FDA Product Code

FSPLOUPE, DIAGNOSTIC/SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896092525]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-04
Device Publish Date2019-01-03

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