Guardian Supporter

GUDID 08809818038043

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.

BM KOREA CO., LTD

Lumbar spine orthosis

• Primary Device ID: 08809818038043
• NIH Device Record Key: 44f188da-5dc5-4de1-ace0-a84931e39f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Supporter
• Version Model Number: GLSO-M
• Company DUNS: 557799209
• Company Name: BM KOREA CO., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter
• Length: 1245 Millimeter
• Width: 320 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809818038043 [Primary]

FDA Product Code

• IQE: Orthosis, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Guardian Supporter]

• 08809818037954: This product is a device that provides support by compressing or immobilizing certain parts of t
• 08809818037961: "This product is a device that provides support by compressing or immobilizing certain parts of
• 08809818038104: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038098: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038081: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038074: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038067: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038050: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038043: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038036: This product is a device designed to provide support by compressing and immobilizing certain par
• 08809818038029: "This product is a device that provides support by compressing or immobilizing certain parts of
• 08809818038012: This product is a device that provides support by compressing or immobilizing certain parts of t
• 08809818038005: "This product is a device that provides support by compressing or immobilizing certain parts of
• 08809818037992: "This product is a device that provides support by compressing or immobilizing certain parts of
• 08809818037985: This product is a device that provides support by compressing or immobilizing certain parts of t
• 08809818037978: "This product is a device that provides support by compressing or immobilizing certain parts of