PlatFORM CM Strip CM46420

GUDID 10813954021840

Collagen Mineral Bone Graft Matrix 20cc (Packaged as two 10cc Strips)

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 10813954021840
• NIH Device Record Key: a221c478-c70e-43e1-8aba-a08f38f511c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlatFORM CM Strip
• Version Model Number: CM46420
• Catalog Number: CM46420
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, INC.
• Device Count: 2
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954021843 [Unit of Use]
GS1	10813954021840 [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: 3
• Public Version Date: 2026-02-27
• Device Publish Date: 2016-08-01

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)