GUDID 00887517055644

EMG ET Tube, 7mm ID Long Elec ENT Kit

Nuvasive, Inc.

Neurophysiologic monitoring system
Primary Device ID00887517055644
NIH Device Record Key8b28ed56-162c-4310-8d92-fa9c5882e0b5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2010870
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
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517055644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSKCuff, tracheal tube, inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-06-01

Devices Manufactured by Nuvasive, Inc.

00195377000040 - ACP2025-05-30 ACP DTS Guide, Mid 0°
00195377000200 - Cohere2025-05-30 COHERE Pivoting Trial, 15x11x34mm 15°
00195377000217 - Cohere2025-05-30 COHERE Pivoting Trial, 14x14x34mm 8°
00195377000224 - Cohere2025-05-30 COHERE Pivoting Trial, 14x14x30mm 8°
00195377000231 - Cohere2025-05-30 COHERE Pivoting Trial, 14x11x34mm 15°
00195377000248 - Cohere2025-05-30 COHERE Pivoting Trial, 13x9x30mm 15°
00195377000255 - Cohere2025-05-30 COHERE Pivoting Trial, 13x14x30mm 8°
00195377000262 - Cohere2025-05-30 COHERE Pivoting Trial, 13x11x34mm 15°
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