DOUBLE PADDLE 1102-REPFI1T

GUDID 00192896050334

DOUBLE PADDLE #1T DOUBLE ENDED SMALL FLARED OPPOSING ANGLED BLADES LIGHT HANDLE TITANIUM

SONTEC INSTRUMENTS, INC.

Dental amalgam condenser, reusable
Primary Device ID00192896050334
NIH Device Record Keyc8f0b9c2-21f7-497a-bdb5-e02d113ce417
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOUBLE PADDLE
Version Model Number1102-REPFI1T
Catalog Number1102-REPFI1T
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896050334 [Primary]

FDA Product Code

EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896050334]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-09-06
Device Publish Date2018-09-17

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