BiomaX

GUDID 00810076560380

BiomaX Bone Graft Putty, 2.5cc

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00810076560380
• NIH Device Record Key: ee597e15-5dbd-44c5-9660-65beecbd0535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiomaX
• Version Model Number: BMX-0002
• Company DUNS: 014520584
• Company Name: Surgalign Spine Technologies, 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: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com
• Phone: (844) 894-7752
• Email: customerservice@surgalign.com

Device Dimensions

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810076560380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071849

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: 2021-11-10
• Device Publish Date: 2021-11-02

On-Brand Devices [BiomaX]

• 00810076560694: BiomaX Bone Graft Putty Plus Chips, 10cc
• 00810076560687: BiomaX Bone Graft Putty Plus Chips, 5cc
• 00810076560670: BiomaX Bone Graft Putty Plus Chips, 2.5cc
• 00810076560663: BiomaX Bone Graft Putty Plus Chips, 1cc
• 00810076560656: BiomaX Bone Graft Putty, 10cc
• 00810076560649: BiomaX Bone Graft Putty, 5cc
• 00810076560380: BiomaX Bone Graft Putty, 2.5cc
• 00810076560007: BiomaX Bone Graft Putty, 1cc