Maxxeus

GUDID 00855318006301

FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE

Dental bone matrix implant, animal-derived

• Primary Device ID: 00855318006301
• NIH Device Record Key: b1f4930a-fe29-444c-bbe4-d1854add1c42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxxeus
• Version Model Number: OK025
• Company DUNS: 071276372
• Company Name: FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855318006301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151209

FDA Product Code

• NPM: Bone Grafting Material, Animal Source

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: 2018-08-30
• Device Publish Date: 2018-07-30

On-Brand Devices [Maxxeus]

• 00855318006325: OL005
• 00855318006318: OK005
• 00855318006301: OK025
• 00855318006295: XL080
• 00855318006288: XL040
• 00855318006271: XL020
• 00855318006264: XK040
• 00855318006257: XK020
• 00855318006240: XK010
• 00855318006233: XK005