Kytocel 3056

GUDID 06931132224092

Foshan United Medical Technologies Ltd.

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 06931132224092
• NIH Device Record Key: d020bf36-376b-4028-8ca5-21557e7c9d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kytocel
• Version Model Number: 2.5x45cm
• Catalog Number: 3056
• Company DUNS: 421269241
• Company Name: Foshan United Medical Technologies 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06931132224092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143124

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: 2023-09-26
• Device Publish Date: 2023-09-18

On-Brand Devices [Kytocel]

• 06931132224092: 2.5x45cm
• 06931132224061: 15x15cm
• 06931132224030: 10x10cm