BoneSync BioActive ABS-3500-10

GUDID 00813954025568

Matrix Strip

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954025568
• NIH Device Record Key: f410de9a-b963-4b04-93c3-bff747f25c3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BoneSync BioActive
• Version Model Number: ABS-3500-10
• Catalog Number: ABS-3500-10
• 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: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.com
• Phone: 239-598-4302
• Email: Customer_Service@Arthrex.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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954025568 [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: 2023-03-16
• Device Publish Date: 2023-03-08

On-Brand Devices [BoneSync BioActive]

• 00813954025032: Matrix Putty
• 00813954025025: Matrix Putty
• 00813954025018: Matrix Putty
• 00813954025001: Matrix Putty
• 00813954024998: Matrix Strip
• 00813954024981: Matrix Strip
• 00813954024974: Matrix Strip
• 00813954024967: Matrix Strip
• 00813954025438: Matrix Putty
• 00813954025582: Matrix Strip
• 00813954025575: Matrix Strip
• 00813954025568: Matrix Strip
• 00813954025551: Matrix Strip
• 00813954025445: Matrix Putty
• 00813954025421: Matrix Putty
• 00813954025414: Matrix Putty