GUDID 00887517159885

NVJJB Sheath, Dynamic Stimulation Ster

Nuvasive, Inc.

Neurophysiologic monitoring system
Primary Device ID00887517159885
NIH Device Record Key7c5c632b-f96b-47da-989a-32f3427f6e8c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2010036
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 Kitfalse
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
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517159885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNSTIMULATOR, NERVE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

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