MD 11

GUDID ENOU20280

Dental implant motor System, SET

Nouvag AG

Remotely-driven dental drilling system motor
Primary Device IDENOU20280
NIH Device Record Keyfa8c8a55-3d44-42eb-b571-1e39442288f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD 11
Version Model Number2028
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
HIBCCENOU20280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[ENOU20280]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-13

On-Brand Devices [MD 11]

ENOU3335SAL0Dental implant motor system
ENOU3335OXY0Dental implant motor system
ENOU3335IDI0Dental implant motor system
ENOU3335ABD0Dental implant motor system
ENOU33350Dental implant motor system
ENOU2028OXY0Dental implant motor System, SET
ENOU2028IDI0Dental implant motor System, SET
ENOU2028ABD0Dental implant motor System, SET
ENOU20280Dental implant motor System, SET
ENOU2027SAL0Dental implant motor System, SET
ENOU2027OXY0Dental implant motor System, SET
ENOU2027M0Dental implant motor System, SET
ENOU2027IDI0Dental implant motor System, SET
ENOU2027ABD0Dental implant motor System, SET
ENOU20270Dental implant motor System, SET
ENOU2026IDI0Dental implant motor System, SET
ENOU20260Dental implant motor System, SET

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