GUDID 00887517159892

NV IPAS III, Bevel Springless (Ster)

Nuvasive, Inc.

Neurophysiologic monitoring system
Primary Device ID00887517159892
NIH Device Record Key246c3949-4a84-4067-86f8-25396dff1e85
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2010037
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
GS100887517159892 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IKNElectromyograph, diagnostic

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 Date2016-09-24

Devices Manufactured by Nuvasive, Inc.

00195377066497 - Cohere2025-02-11 COHERE ALIF Interbody, 10x42x32mm 10°
00195377067005 - Cohere2025-02-11 COHERE ALIF Interbody, 10x42x32mm 15°
00195377067012 - Cohere2025-02-11 COHERE ALIF Interbody, 10x42x32mm 20°
00195377067029 - Cohere2025-02-11 COHERE ALIF Interbody, 10x42x32mm 25°
00195377067036 - Cohere2025-02-11 COHERE ALIF Interbody, 10x42x32mm 30°
00195377067043 - Cohere2025-02-11 COHERE ALIF Interbody, 10x34x24mm 20°
00195377067050 - Cohere2025-02-11 COHERE ALIF Interbody, 10x34x24mm 25°
00195377067067 - Cohere2025-02-11 COHERE ALIF Interbody, 10x34x24mm 30°

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.