AccessGUDID - DEVICE: GUARDIAN-SG Inflatable Bone Expander System (08809255540987)

GUDID

Device Identifier (DI) Information

Brand Name: GUARDIAN-SG Inflatable Bone Expander System
Version or Model: 2BMK(T)15αS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BM KOREA CO., LTD

Primary DI Number: 08809255540987
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557799209 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17541	Catheter/overtube balloon inflator, single-use	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope
NDN	Cement, Bone, Vertebroplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143006	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: temperature limitation, from -10℃ to 25℃

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Millimeter

Device Record Status

Public Device Record Key: 1b10e82e-871e-4c6b-9647-9606cecbcc9d
Public Version Date: May 06, 2020
Public Version Number: 6
DI Record Publish Date: June 21, 2017