OssiMend Block MCCB10

GUDID 00813954026886

Bone Graft Matrix

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954026886
• NIH Device Record Key: a73de674-f641-4b74-89f7-ca78679638c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OssiMend Block
• Version Model Number: MCCB10
• Catalog Number: MCCB10
• 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: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.com
• Phone: (201) 405-1477
• Email: contact@regenity.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 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
• 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	00813954026886 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-27
• Device Publish Date: 2025-03-19

On-Brand Devices [OssiMend Block]

• 00813954022185: Bone Graft Matrix (10cc), 12.5 x 2 x 0.4cm Strip
• 00813954022178: Bone Graft Matrix (5cc), 12.5 x 1 x 0.4cm Strip
• 00813954022161: Bone Graft Matrix (20cc), 6.25 x 2 x 0.8cm, 2 Strips
• 00813954022154: Bone Graft Matrix (10cc), 6.25 x 2 x 0.8cm Strip
• 00813954022147: Bone Graft Matrix (5cc), 6.25 x 2 x 0.4cm Strip
• 10813954022113: Bone Graft Matrix 12.5 x 2 x 0.4cm Strip (2 Strips per box)
• 00813954020860: Bone Graft Matrix
• 00813954020853: Bone Graft Matrix
• 00813954020846: Bone Graft Matrix
• 00813954020839: Bone Graft Matrix
• 00813954020822: Bone Graft Matrix
• 00813954026893: Bone Graft Matrix
• 00813954026886: Bone Graft Matrix