InterGro DBM Plus DBMW10

GUDID 00888480585251

DBM in a Lipid Carrier with Porous Calcium Granules

Biomet Orthopedics, LLC

Bone matrix implant, human-derived

• Primary Device ID: 00888480585251
• NIH Device Record Key: 9b012d3c-69fa-4bd4-9193-4d83698039be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterGro DBM Plus
• Version Model Number: DBMW10
• Catalog Number: DBMW10
• 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	00888480585251 [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 Plus]

• 00888480585251: DBM in a Lipid Carrier with Porous Calcium Granules
• 00888480585220: DBM in a Lipid Carrier with Porous Calcium Granules
• 00888480585213: DBM in a Lipid Carrier with Porous Calcium Granules
• 00888480585206: Porous Hydroxyapatite Bone Graft Substitute