Vitoss BiModal 2102-1902

GUDID 00808232000634

Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, and Bioactive Glass

Stryker Corporation

Bone matrix implant, composite

• Primary Device ID: 00808232000634
• NIH Device Record Key: 2dea928b-925a-4280-9f6e-35a3f06537f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitoss BiModal
• Version Model Number: 2102-1902
• Catalog Number: 2102-1902
• Company DUNS: 149183167
• Company Name: Stryker Corporation
• 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: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com
• Phone: +1(610)640-1775
• Email: spacustserv@stryker.com

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Ambient
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Expose to Extreme Heat
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808232000634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103173

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

On-Brand Devices [Vitoss BiModal]

• 00808232000658: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
• 00808232000641: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
• 00808232000634: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
• 00808232000627: Bioactive Bone Graft Substitute, Foam Pack; Beta-Tricalcium Phosphate, Type I Bovine Collagen, a
• 07613327277258: Foam Strip
• 07613327277241: Foam Strip
• 07613327277234: Foam Strip
• 07613327277227: Foam Strip