GUDID 00195377164261

XATP Access Articulating Arm, 45°

Nuvasive, Inc.

Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable
Primary Device ID00195377164261
NIH Device Record Keycf5bf0e7-85d7-4c70-a0a3-759e261ed129
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberZ200288
Company DUNS053950783
Company NameNuvasive, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195377164261 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


[00195377164261]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-15
Device Publish Date2024-01-05

Devices Manufactured by Nuvasive, Inc.

00887517063045 - VuePoint2024-04-15 VuePoint II Cutter, Rod
00887517063052 - SpheRx2024-04-15 SpheRx PPS Counter Torque, Reduction
00887517065216 - Precept2024-04-15 PRECEPT Handle, Fascial Splitting
00887517075376 - NVJJB2024-04-15 NVJJB EMG Harness Extensions
00887517078568 - PCM2024-04-15 PCM Slap Hammer
00887517084187 - VuePoint2024-04-15 VuePoint II Handle, Universal
00887517084644 - VuePoint2024-04-15 VP II Handle, Torque Final Tightening
00887517084675 - VuePoint2024-04-15 VP II Handle, Torque Rod-Rod Driver

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.