Proxeo ULTRA PB-510

GUDID J021303230000

Ultrasonic scaler drive unit

W & H Dentalwerk Bürmoos GmbH

Dental ultrasonic surgical system generator
Primary Device IDJ021303230000
NIH Device Record Key80a04ec9-7310-48d1-9e6f-a5c4880a787a
Commercial Distribution StatusIn Commercial Distribution
Brand NameProxeo ULTRA PB-510
Version Model Number30323000
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
HIBCCJ021303230000 [Direct Marking]
HIBCCJ021303230001 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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