PlatFORM CM Strip

GUDID 00813954021010

Collagen Mineral Bone Graft Matrix

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954021010
• NIH Device Record Key: 8040b480-c2b5-4ce8-8917-6a6f5c64b0a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlatFORM CM Strip
• Version Model Number: CM46410
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, 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: false
• 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: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.com
• Phone: 1-800-447-3625
• Email: spinecomplaints@highridgemedical.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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954021010 [Previous]
GS1	00813954021850 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-22

On-Brand Devices [PlatFORM CM Strip]

• 00813954021003: Collagen Mineral Bone Graft Matrix
• 00813954021010: Collagen Mineral Bone Graft Matrix
• 10813954021840: Collagen Mineral Bone Graft Matrix 20cc (Packaged as two 10cc Strips)