GUARDIAN-SG Inflatable Bone Expander System

GUDID 08809255540987

The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.

BM KOREA CO., LTD

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 08809255540987
• NIH Device Record Key: 1b10e82e-871e-4c6b-9647-9606cecbcc9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUARDIAN-SG Inflatable Bone Expander System
• Version Model Number: 2BMK(T)15αS
• 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: true
• 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: 15 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *temperature limitation, from -10℃ to 25℃

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809255540987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143006

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: 6
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-06-21

On-Brand Devices [GUARDIAN-SG Inflatable Bone Expander System]

• 08809255544633: The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of frac
• 08809255540987: The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of frac