FormaGraft

GUDID 00887517238436

FormaGraft® Granules, 10cc

Nuvasive, Inc.

Bone matrix implant, composite

• Primary Device ID: 00887517238436
• NIH Device Record Key: fba5ffbb-8914-4cca-908b-a5519207eee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FormaGraft
• Version Model Number: 5010010
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +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
• 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
• Phone: +1800-475-9131
• Email: nuvainfo@globusmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517238436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050789

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-19

On-Brand Devices [FormaGraft]

• 00887517517500: Booth Biologics Tradeshow
• 00887517239372: FormaGraft® Strips, Small
• 00887517239365: FormaGraft® Strips, Large
• 00887517239310: FormaGraft® XL Blocks, Large
• 00887517238450: FormaGraft® XL Blocks, Small
• 00887517238443: FormaGraft® Granules, 20cc
• 00887517238436: FormaGraft® Granules, 10cc
• 00887517238412: FormaGraft® Granules, 5cc
• 00887517238429: FormaGraft BMA Needle, 8" Packaged
• 00887517237392: FormaGraft BMA Needle, 6-Port (1)