Guardian Splint

GUDID 08809818038203

This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.

BM KOREA CO., LTD

Assistive dynamic arm support system

• Primary Device ID: 08809818038203
• NIH Device Record Key: 87d8880a-3f9e-43a6-b5a6-62b736f0ffc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Splint
• Version Model Number: GSACU-LR
• 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: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter
• Length: 230 Millimeter
• Width: 95 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809818038203 [Primary]

FDA Product Code

• ILH: Splint, Hand, And Components

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: 2025-03-31
• Device Publish Date: 2025-03-21

On-Brand Devices [Guardian Splint]

• 08809818038166: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038159: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038142: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038135: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038128: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038111: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038258: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038241: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038234: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038227: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038210: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038203: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038197: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038180: This product is made by molding thermoplastic synthetic resin to the affected area, and is used
• 08809818038173: This product is made by molding thermoplastic synthetic resin to the affected area, and is used