HighSurg 11

GUDID ENOU3391FOC0

Surgical motor system

Nouvag AG

Line-powered surgical power tool system motor
Primary Device IDENOU3391FOC0
NIH Device Record Key359f6b62-7577-4d4e-8e22-20b9fd20d133
Commercial Distribution StatusIn Commercial Distribution
Brand NameHighSurg 11
Version Model Number3391FOC
Company DUNS480610476
Company NameNouvag AG
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

Customer Support Contacts

Phone+41718466600
Emailinfo@nouvag.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCENOU3391FOC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBCMotor, Drill, Electric

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[ENOU3391FOC0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-21
Device Publish Date2018-08-21

On-Brand Devices [HighSurg 11]

ENOU3391FOC0Surgical motor system
ENOU33910Surgical motor system
ENOU33610Surgical motor system

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