Modulus

GUDID 00887517833877

Alpha Modulus TLIF-O Implant Set 2

Nuvasive, Inc.

Sterilization/disinfection container

• Primary Device ID: 00887517833877
• NIH Device Record Key: 8a3caf8c-b42e-484e-8649-ba2b2e646d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modulus
• Version Model Number: ALPMDLUSTLIFOIMP2
• 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
• 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: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517833877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143579

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-10
• Device Publish Date: 2018-05-04

On-Brand Devices [Modulus]

• 00887517969163: Modulus-C Shaft, Inserter Retention
• 00887517969156: Modulus-C Inserter, w/Depth Stop
• 00887517969149: Modulus-C Inserter
• 00887517968814: Modulus TLIF-A Inserter
• 00887517945419: Modulus TLIF-O Inserter, Low-Profile
• 00887517931382: Modulus TLIF Inserter, Dism Trial
• 00887517913425: Modulus XLIF Inserter
• 00887517913418: Modulus XLIF Handle, Inserter
• 00887517913401: Modulus XLIF Inserter, Plate Modular
• 00887517840882: Modulus TLIF-O Inserter, Zero-Profile
• 00887517996060: Modulus TLIF-A Implant Set - XL
• 00887517996053: Modulus TLIF-A Trial Set - Outlier
• 00887517996046: Modulus TLIF-A Implant Set - Outlier
• 00887517996039: Modulus TLIF-A Implant Set - Core
• 00887517992567: Modulus TLIF-A XL Ins
• 00887517992550: Modulus TLIF-A Core Ins
• 00887517992123: Modulus TLIF-A Removal Clip
• 00887517988096: Modulus TLIF-A Inserter, Offset
• 00887517869692: Modulus TLIF-A, 14x9x30mm 8°
• 00887517869098: Modulus TLIF-A, 14x14x30mm 8°
• 00887517867490: Modulus TLIF-A, 14x11x34mm 8°
• 00887517862297: Modulus TLIF-A, 12x14x40mm 8°
• 00887517858696: Modulus TLIF-A, 11x14x40mm 8°
• 00887517858498: Modulus TLIF-A, 11x14x34mm 8°
• 00887517858474: Modulus TLIF-A, 11x14x34mm 15°
• 00887517858290: Modulus TLIF-A, 11x14x30mm 8°
• 00887517856692: Modulus TLIF-A, 11x11x34mm 8°
• 00887517855091: Modulus TLIF-A, 10x14x40mm 8°
• 00887517851499: Modulus TLIF-A, 9x14x40mm 8°
• 00887517851291: Modulus TLIF-A, 9x14x34mm 8°
• 00887517851277: Modulus TLIF-A, 9x14x34mm 15°
• 00887517851093: Modulus TLIF-A, 9x14x30mm 8°
• 00887517849496: Modulus TLIF-A, 9x11x34mm 8°
• 00887517847898: Modulus TLIF-A, 8x14x40mm 8°
• 00887517844491: Modulus TLIF-A, 7x9x30mm 8°
• 00887517844095: Modulus TLIF-A, 7x14x34mm 8°
• 00887517843890: Modulus TLIF-A, 7x14x30mm 8°
• 00887517842299: Modulus TLIF-A, 7x11x34mm 8°
• 00887517842091: Modulus TLIF-A, 7x11x30mm 8°
• 00887517727442: Modulus XLXW, 12x26x60mm 10°
• 00887517727428: Modulus XLXW, 12x26x55mm 10°
• 00887517727404: Modulus XLXW, 12x26x50mm 10°
• 00887517727381: Modulus XLXW, 12x26x45mm 10°
• 00887517727367: Modulus XLXW, 10x26x60mm 10°
• 00887517727343: Modulus XLXW, 10x26x55mm 10°
• 00887517727329: Modulus XLXW, 10x26x50mm 10°
• 00887517727305: Modulus XLXW, 10x26x45mm 10°
• 00887517883896: Modulus TLIF-O, 14x10x30mm 8°
• 00887517883858: Modulus TLIF-O, 14x10x30mm 4°
• 00887517883834: Modulus TLIF-O, 14x10x30mm 12°