GUARDIAN Inflatable Bone Expander System - The GUARDIAN Inflatable Bone Expander System is - BM KOREA CO., LTD

Duns Number:557799209

Device Description: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression frac 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.

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More Product Details

Catalog Number

-

Brand Name

GUARDIAN Inflatable Bone Expander System

Version/Model Number

BMK-CM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111593,K111593

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

489f02eb-bc0e-44c3-b203-bbeffa1a94d0

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

February 14, 2018

Additional Identifiers

Package DI Number

08809255544213

Quantity per Package

10

Contains DI Package

08809255542219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BM KOREA CO., LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 149