iVAS

Basic Information

• Brand Name: iVAS
• Primary DI: 07613327142716
• Version / Model: 808115000
• Catalog Number: 0808-115-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-08
• Public Version: 4
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: 662b04a3-5fa0-466c-b996-e72d359f94b1

Device Description

11 gauge 15mm iVAS Elite Single Balloon Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
47129	Balloon kyphoplasty kit	A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp 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, and filling the void created with orthopaedic cement/filler 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	37613327142717	GS1	pack	3	In Commercial Distribution
Primary	07613327142716	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	11.0	Gauge
Device Size Text, specify			Balloon Length: 15.0 Millimeter

Storage Conditions

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