Sterile Silver Alginate Wound Dressing

GUDID 16934889085098

QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 16934889085098
• NIH Device Record Key: 4b5599a5-e122-4e0f-8919-ff23ba4c7023
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Silver Alginate Wound Dressing
• Version Model Number: 0.8in×17.6in (2cm×44cm)
• Company DUNS: 421362069
• Company Name: QINGDAO BRIGHT MOON BIOMATERIALCO., 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934889085091 [Primary]
GS1	16934889085098 [Package]; Contains: 06934889085091; Package: [5 Units]; In Commercial Distribution
GS1	26934889085095 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220673

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: 2025-05-06
• Device Publish Date: 2025-04-28

On-Brand Devices [Sterile Silver Alginate Wound Dressing]

• 16934889086194: 4in×5in (10cm×12.5cm)
• 16934889085098: 0.8in×17.6in (2cm×44cm)
• 16934889085029: 3in×4.8in (7.5cm×12cm)
• 16934889085104: 4.25in×4.25in (11cm×11cm)