Scaler Tip 3Rm

GUDID J021063685001

Tip 3Rm with tip changer

W & H Dentalwerk Bürmoos GmbH

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device IDJ021063685001
NIH Device Record Key6d6749c6-b344-48ac-b2b5-c4794e2a5e39
Commercial Distribution StatusIn Commercial Distribution
Brand NameScaler Tip 3Rm
Version Model Number06368500
Company DUNS300238441
Company NameW & H Dentalwerk Bürmoos GmbH
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ021063685001 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


[J021063685001]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

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