GUDID 00887517163233

NVM5 EMG ET Tube, 8mm ENT Kit

Nuvasive, Inc.

Neurophysiologic monitoring system
Primary Device ID00887517163233
NIH Device Record Keyd1b0a8df-c8f4-4172-9f6e-82fa59593772
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2010480
Company DUNS053950783
Company NameNuvasive, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517163233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTRTube, tracheal (w/wo connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-20
Device Publish Date2019-11-12

Devices Manufactured by Nuvasive, Inc.

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