- Physicians Office Resource

11 gauge 15mm iVAS Elite Balloon Catheter
iVAS - 808115500

Device Description

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.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

60.00
10.00

Storage Environment Temperature - Degrees Celsius

25.00
12.00

Device Sizes

Balloon Length: 15.0 Millimeter

Needle Gauge: 11.0 Gauge

Balloon Length: 15.0 Millimeter
Needle Gauge: 11.0 Gauge

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NDN

Device Name: Cement, Bone, Vertebroplasty

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3027

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 37613327142762

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327142761

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613327142761

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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