Guardian Supporter

GUDID 08809818037985

This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement.

BM KOREA CO., LTD

Lumbar spine orthosis

• Primary Device ID: 08809818037985
• NIH Device Record Key: e2224a3b-c547-4d22-9dbc-8235c56a103e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Supporter
• Version Model Number: GCSET-XL
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08809818037985 [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