GUARDIAN Inflatable Bone Expander System

GUDID 08809255544169

The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN Inflatable Bone Expander System are the significant reduction in back pain and increase patient’s functional abilities, allow a return it the previous level of activity.

BM KOREA CO., LTD

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 08809255544169
• NIH Device Record Key: 5d905f34-f42b-4592-9eaf-6e161dc77cf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUARDIAN Inflatable Bone Expander System
• Version Model Number: BMK15BC
• Company DUNS: 557799209
• Company Name: BM KOREA CO., LTD
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Length: 303 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809255542165 [Primary]
GS1	08809255544169 [Package]; Contains: 08809255542165; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111593

FDA Product Code

• HRX: Arthroscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-02-14

On-Brand Devices [GUARDIAN Inflatable Bone Expander System ]

• 08809255544817: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture a
• 08809255542707: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture a
• 08809255544213: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture a
• 08809255544169: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture a