AccessGUDID - DEVICE: Guardian Supporter (08809818038296)

GUDID

Device Identifier (DI) Information

Brand Name: Guardian Supporter
Version or Model: GWT-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BM KOREA CO., LTD

Primary DI Number: 08809818038296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557799209 *Terms of Use

Device Description: This product is a device designed to provide support by compressing and immobilizing certain parts of the body (such as the waist, knees, wrists, or back); products that do not offer support or stabilization are excluded.

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
64398	Thoracic cage orthosis force meter	An electronic device designed to measure the force on the compression plate of a thoracic cage orthosis when worn by a patient, or to estimate thoracic elasticity prior to applying a thoracic cage orthosis. These measurements are used to facilitate decisions about the modification of custom treatment parameters. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNE	Orthosis, Moldable, Supportive, Skin Protective

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 210 Millimeter
Width: 210 Millimeter

Device Record Status

Public Device Record Key: 7ae7e71f-2e94-4e21-a04b-f6dc3cb11d96
Public Version Date: July 01, 2025
Public Version Number: 1
DI Record Publish Date: June 23, 2025