McCALL SCALER/CURETTE 1102-SCM17-18

GUDID 00192896055605

McCALL SCALER/CURETTE DOUBLE ENDED

SONTEC INSTRUMENTS, INC.

Manual dental scaler, reusable
Primary Device ID00192896055605
NIH Device Record Keyc15409d0-0113-4437-b062-05ef298a95ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameMcCALL SCALER/CURETTE
Version Model Number1102-SCM17-18
Catalog Number1102-SCM17-18
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 Identifiers

Device Issuing AgencyDevice ID
GS100192896055605 [Primary]

FDA Product Code

EMKCURETTE, SURGICAL, DENTAL
EMNScaler, Periodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896055605]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-29
Device Publish Date2018-09-17

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