Dimora

GUDID 16941094019091

Winner Medical Co., Ltd.

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

• Primary Device ID: 16941094019091
• NIH Device Record Key: 2b3efd67-4ace-4742-ac2d-45ecdbbca891
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dimora
• Version Model Number: 603-012061
• Company DUNS: 530629351
• Company Name: Winner Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	16941094019091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143335

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: 2020-02-18
• Device Publish Date: 2020-02-10

On-Brand Devices [Dimora]

• 16941094019091: 603-012061
• 26941094064180: Sacrum Silicone AG Foam Dressing with Border
• 26941094064142: Silicone AG Foam Dressing with Border
• 26941094047282: PHMB Foam Dressing without Border
• 26941094025471: Silicone AG Foam Dressing with Border