Opus™ BA Putty 71410314

GUDID 00813954025506

Osteoconductive Matrix

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954025506
• NIH Device Record Key: 98d5fd72-11cf-46f1-a524-3074bca2b480
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opus™ BA Putty
• Version Model Number: 71410314
• Catalog Number: 71410314
• 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: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.com
• Phone: 888-298-5700
• Email: OSI-CustomerService@Orthofix.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
• 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
• 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	00813954025506 [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: 2023-04-28
• Device Publish Date: 2023-04-20

On-Brand Devices [Opus™ BA Putty]

• 00813954025544: Osteoconductive Matrix
• 00813954025537: Osteoconductive Matrix
• 00813954025520: Osteoconductive Matrix
• 00813954025513: Osteoconductive Matrix
• 00813954025506: Osteoconductive Matrix
• 00813954025490: Osteoconductive Matrix