PCD, VertaPlex 0507-586-000

GUDID 37613327357852

Precision System with Extension Tube and HV Bone Cement

STRYKER CORPORATION

Orthopaedic cement preparation/delivery kit Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial

• Primary Device ID: 37613327357852
• NIH Device Record Key: 89db87b4-30bf-49ce-87d3-5b99a066f99d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCD, VertaPlex
• Version Model Number: 0507586000
• Catalog Number: 0507-586-000
• Company DUNS: 196548481
• 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: true
• 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(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@stryker.com

Device Dimensions

• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree
• Angle: 90 degree

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327357851 [Primary]
GS1	37613327357852 [Package]; Contains: 07613327357851; Package: pack [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150582

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-03
• Device Publish Date: 2017-04-21

On-Brand Devices [PCD, VertaPlex]

• 37613327357869: Precision System with Extension Tube and Bone Cement
• 37613327357852: Precision System with Extension Tube and HV Bone Cement
• 37613327357845: Precision System with Short Extension Tube and Bone Cement
• 37613252018316: Precision System Kit with Short Extension Tube and HV Bone Cement