Propel

GUDID 00887517971548

Propel DBM Gel Plus, 1cc OUS

Nuvasive, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00887517971548
• NIH Device Record Key: 86cd0d44-97aa-47f3-9475-583ffbd2cd4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Propel
• Version Model Number: 5020401994
• 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: +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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517971548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103036

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-21
• Device Publish Date: 2018-12-20

On-Brand Devices [Propel]

• 00887517971586: Propel DBM Gel Plus, 8cc OUS
• 00887517971579: Propel DBM Gel Plus, 8cc
• 00887517971562: Propel DBM Gel Plus, 3cc OUS
• 00887517971555: Propel DBM Gel Plus, 3cc
• 00887517971548: Propel DBM Gel Plus, 1cc OUS
• 00887517971531: Propel DBM Gel Plus, 1cc
• 00887517971524: Propel DBM Gel, 10cc OUS
• 00887517971517: Propel DBM Gel, 10cc
• 00887517971500: Propel DBM Gel, 5cc OUS
• 00887517970497: Propel DBM Gel, 5cc
• 00887517970480: Propel DBM Gel, 1cc OUS
• 00887517970473: Propel DBM Gel, 1cc
• 00887517970466: Propel DBM Putty Plus, 10cc OUS
• 00887517970459: Propel DBM Putty Plus, 10cc
• 00887517970442: Propel DBM Putty Plus, 5cc OUS
• 00887517970435: Propel DBM Putty Plus, 5cc
• 00887517614384: Propel Putty, Large
• 00887517614377: Propel Putty, Medium
• 00887517614360: Propel Putty, Small