iVAS

Basic Information

• Brand Name: iVAS
• Primary DI: 07613327142723
• Version / Model: 808010500
• Catalog Number: 0808-010-500
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-11
• Public Version: 3
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: 3ecb9cf9-ad6f-46c7-bed0-0fd2b6fd9e7f

Device Description

10 gauge 10mm iVAS Elite Balloon Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDN	CEMENT, BONE, VERTEBROPLASTY	Orthopedic	888.3027	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47021	Inflatable bone tamp	A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613327142724	GS1	pack	3	In Commercial Distribution
Primary	07613327142723	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Balloon Length: 10.0 Millimeter
Needle Gauge	10.0	Gauge

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 12 – 25 Degrees Celsius