iVAS 0306-531-000

GUDID 37613327297783

Bevel Stylet

STRYKER CORPORATION

Bone access cannula

• Primary Device ID: 37613327297783
• NIH Device Record Key: c3397b09-540d-4313-b6cf-0172625d555e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iVAS
• Version Model Number: 0306-531-000
• Catalog Number: 0306-531-000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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(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

• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327297782 [Primary]
GS1	37613327297783 [Package]; Contains: 07613327297782; Package: pack [6 Units]; In Commercial Distribution

FDA Product Code

• OAR: Injector, vertebroplasty (does not contain cement)

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: 2016-09-23

On-Brand Devices [iVAS]

• 37613327389815: BONE BIOPSY KIT
• 07613327374483: Inflatable Vertebral Augmentation System
• 07613327374476: Inflatable Vertebral Augmentation System
• 07613327374469: Inflatable Vertebral Augmentation System
• 37613327374453: ACCESS CANNULA
• 07613327358346: 8 gauge 15mm iVAS Elite Fracture Kit
• 07613327358339: 11 gauge 15mm iVAS Elite Fracture Kit
• 07613327358322: 8 gauge 20mm iVAS Elite Fracture Kit
• 07613327358315: 11 gauge 10mm iVAS Elite Fracture Kit
• 07613327358308: 10 gauge 10mm iVAS Elite Fracture Kit
• 07613327358278: 10 gauge 15mm iVAS Elite Fracture Kit
• 37613327297783: Bevel Stylet
• 37613327297776: Bevel Stylet
• 37613327142793: 8 gauge 20mm iVAS Elite Single Kit
• 37613327142786: 10 gauge 15mm iVAS Elite Single Balloon Kit
• 37613327142779: 8 gauge 15mm iVAS Elite Single Balloon Kit
• 37613327142762: 11 gauge 15mm iVAS Elite Balloon Catheter
• 37613327142755: 10 gauge 20mm iVAS Elite Balloon Catheter
• 37613327142748: 11 gauge 10mm iVAS Elite Balloon Catheter
• 37613327142731: 10 gauge 15mm iVAS Elite Balloon Catheter
• 37613327142724: 10 gauge 10mm iVAS Elite Balloon Catheter
• 37613327142717: 11 gauge 15mm iVAS Elite Single Balloon Kit
• 37613327142700: 11 gauge 10mm iVAS Elite Single Kit
• 37613327142694: 10 gauge 20mm iVAS Elite Single Kit
• 37613327142687: 10 gauge 10mm iVAS Elite Single Kit
• 37613252594209: Bone Biopsy Kit
• 37613252506004: Balloon Catheter
• 37613252505991: Access Cannula
• 37613252505984: Inflatable Vertebral Augmentation System
• 37613252505977: Ballon Catheter
• 37613252505960: Inflatable Vertabral Augmentation System
• 37613252467909: Inflatable Vertebral Augmentation System
• 37613252293171: Balloon Catheter
• 37613252293164: Infaltable Vertebral Augmentation System
• 37613252276280: Inflatable Vertebral Augmentation System
• 37613252276273: Inflatable Vertebral Augmentation System
• 37613252202623: Bone Biopsy Kit
• 37613252170519: Bone Biopsy Kit
• 37613252170502: Bevel Stylet
• 37613252170496: Access Cannula
• 37613252163627: Balloon Catheter
• 37613252163610: Inflatable Vertebral Augmentation System
• 37613252158784: Access Cannula
• 37613252052020: Balloon Catheter
• 37613252029831: Inflatable Vertebral Augmentation System
• 07613327358292: 10 gauge 10mm iVAS Elite Single Kit