AVAflex 1031115000

GUDID 07613327374605

11 gauge 15mm AVAflex Vertebral Balloon System

STRYKER CORPORATION

Balloon kyphoplasty kit

• Primary Device ID: 07613327374605
• NIH Device Record Key: ff51a32f-2bb1-4047-9916-65e7edd72b11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVAflex
• Version Model Number: 1031115000
• Catalog Number: 1031115000
• 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

Device Dimensions

• Device Size Text, specify: 0
• Needle Gauge: 11 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 12 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327374605 [Primary]

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

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: 2018-06-04
• Device Publish Date: 2018-05-04

On-Brand Devices [AVAflex]

• 07613327374629: AVAflex Curved Needle
• 07613327374612: AVAflex Curved Needle Kit
• 07613327374605: 11 gauge 15mm AVAflex Vertebral Balloon System
• 07613327374599: 10 gauge 30mm AVAflex Vertebral Balloon System
• 07613327374582: 11 gauge 20mm AVAflex Vertebral Balloon System
• 07613327374575: 10 gauge 20mm AVAflex Vertebral Balloon System
• 07613327374568: 10 gauge 15mm AVAflex Vertebral Balloon System
• 07613327374551: 11 gauge 30mm AVAflex Vertebral Balloon System