SpeedControl SC1 (M-UK1023)

GUDID J021303870020

Medical Surgical Unit (230V) for RIWOSpine

W & H Dentalwerk Bürmoos GmbH

Surgical power tool system control unit, line-powered
Primary Device IDJ021303870020
NIH Device Record Keya98e57aa-1106-4ff9-a8f0-71e808b399ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeedControl SC1 (M-UK1023)
Version Model Number30387002
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
HIBCCJ021303870020 [Direct Marking]
HIBCCJ021303870021 [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 Date2023-10-20
Device Publish Date2023-10-12

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