UNCHARTED

GUDID 06940610128968

Huizhou Foryou Medical Devices Co., Ltd.

Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

• Primary Device ID: 06940610128968
• NIH Device Record Key: 92713bcc-6828-48d2-b534-9b285117e376
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNCHARTED
• Version Model Number: 50×50mm
• Company DUNS: 529904325
• Company Name: Huizhou Foryou Medical Devices Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06940610128968 [Primary]

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

Devices Manufactured by Huizhou Foryou Medical Devices Co., Ltd.

• 06940610128968 - UNCHARTED: 2024-02-27
• 06940610128968 - UNCHARTED: 2024-02-27
• 16940610101760 - HEMOCELL: 2021-04-01 HEMOCELL Soluble Dental Gauze Dressing
• 26940610100500 - SureStop: 2020-06-03 SureStop Topical Hemostatic Dressing