InterGro DBM Paste DBM001

GUDID 00888480585121

Demineralized Bone Matrix (DBM) in a Lipid Carrier

Biomet Orthopedics, LLC

Bone matrix implant, human-derived

• Primary Device ID: 00888480585121
• NIH Device Record Key: 739cc14e-0d76-4554-a8ab-118cb8371528
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterGro DBM Paste
• Version Model Number: DBM001
• Catalog Number: DBM001
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 1-800-348-9500
• Email: customerservice@biomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888480585121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082793

FDA Product Code

• MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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: 2015-10-24

On-Brand Devices [InterGro DBM Paste]

• 00888480585145: Demineralized Bone Matrix (DBM) in a Lipid Carrier
• 00888480585138: Demineralized Bone Matrix (DBM) in a Lipid Carrier
• 00888480585121: Demineralized Bone Matrix (DBM) in a Lipid Carrier