Vitoss BiModal 2102-1820

GUDID 07613327277227

Foam Strip

Stryker Corporation

Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite

• Primary Device ID: 07613327277227
• NIH Device Record Key: 5fb734b4-ac33-4bf3-8311-2d3bd0b4b992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitoss BiModal
• Version Model Number: 2102-1820
• Catalog Number: 2102-1820
• 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

Device Dimensions

• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Width: 25 Millimeter
• Length: 100 Millimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327277227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153608

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: 2016-04-01

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