GUDID 00195377166517

Simplify Adjustable Stop, Single-Sided

Nuvasive, Inc.

Internal spinal fixation procedure kit, reusable

• Primary Device ID: 00195377166517
• NIH Device Record Key: 66dd7589-5d7e-440d-b790-358aa3f30a86
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Z700342
• Company DUNS: 053950783
• Company Name: Nuvasive, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195377166517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200022

FDA Product Code

• MJO: Prosthesis, intervertebral disc

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

[00195377166517]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-15
• Device Publish Date: 2024-01-05

Devices Manufactured by Nuvasive, Inc.

• 00195377068101 - ReLine: 2024-12-05 EELINE C Eyelet - Double Short
• 00887517066947 - Instruments: 2024-12-05 ALGI Forceps, Bipolar Angled Long
• 00887517177322 - MaXcess: 2024-12-05 MAS Micro Decomp Forceps, Bipolar Ang
• 00887517721518 - VersaTie: 2024-12-05 VersaTie Band, 4.5mm Hook/Malleable End
• 00887517733283 - CoRoent: 2024-12-05 CoRoent Ant TLIF Ti, 12x9x30mm 12°
• 00195377041593 - ReLine: 2024-11-29 RELINE-One Screw, 5.5x35mm 2C EXTTAB
• 00195377041609 - ReLine: 2024-11-29 RELINE-One Screw, 5.5x40mm 2C EXTTAB
• 00195377041616 - ReLine: 2024-11-29 RELINE-One Screw, 5.5x45mm 2C EXTTAB