NexGraft NBF1-100X25-15

GUDID 00816125022090

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, composite

• Primary Device ID: 00816125022090
• NIH Device Record Key: a1090940-7c8c-41eb-9c4e-0afe9bac1f91
• Commercial Distribution Discontinuation: 2016-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NexGraft
• Version Model Number: NBF1-100X25-15
• Catalog Number: NBF1-100X25-15
• Company DUNS: 081067703
• Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC
• 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: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816125022090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092046

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: 4
• Public Version Date: 2019-12-19
• Device Publish Date: 2016-04-08

On-Brand Devices [NexGraft]

• 00816125022090: NBF1-100X25-15
• 00816125022083: NBF1-100X25-10
• 00816125022076: NBF1-90X22-07
• 00816125022069: NBF1-90X22-10
• 00816125022052: NBF2-50X25-10
• 00816125022045: NBF2-50X10-05
• 00816125022038: NBF1-50X10-02
• 00816125022021: NBF2-50X10-02
• 00816125022014: NBF1-50X10-01