Vitoss BA Injectable 2102-2305

GUDID 07613327064797

Bone graft substitute

Stryker Orthobiologics

Bone matrix implant, synthetic

• Primary Device ID: 07613327064797
• NIH Device Record Key: 354abb18-b89a-4a4c-9ec3-bcae24360f7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitoss BA Injectable
• Version Model Number: 2102-2305
• Catalog Number: 2102-2305
• Company DUNS: 849227939
• Company Name: Stryker Orthobiologics
• Device Count: 1
• DM Exempt: true
• 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: false
• 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(610)640-1775
• Email: spacustserv@stryker.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327064797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163621

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: 2018-07-06
• Device Publish Date: 2017-07-12

On-Brand Devices [Vitoss BA Injectable]

• 07613327064797: Bone graft substitute
• 07613327064780: Bone graft substitute
• 07613327064773: Bone graft substitute