Piezomed Pro M-PM100

GUDID J021305000000

Piezomed Pro Module

W & H Dentalwerk Bürmoos GmbH

Hard/soft-tissue ultrasonic surgical system
Primary Device IDJ021305000000
NIH Device Record Key79ad8a04-c77e-49fb-b9be-4128694c79c8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiezomed Pro M-PM100
Version Model Number30500000
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
HIBCCJ021305000000 [Direct Marking]
HIBCCJ021305000001 [Primary]

FDA Product Code

ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-16
Device Publish Date2025-07-08

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

J021305030001 - Piezomed Pro Accessory2025-09-30 Instrument MP1-S
J021305030011 - Piezomed Pro Accessory2025-09-30 Instrument MR1-S
J021305030021 - Piezomed Pro Accessory2025-09-30 Instrument MR2-S
J021305030031 - Piezomed Pro Accessory2025-09-30 Instrument MR3-S
J021305030041 - Piezomed Pro Accessory2025-09-30 Instrument MR4-S
J021305030051 - Piezomed Pro Accessory2025-09-30 Instrument MR5-S
J021305030061 - Piezomed Pro Accessory2025-09-30 Instrument MR6-S
J021305030071 - Piezomed Pro Accessory2025-09-30 Instrument MS1-S

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