Kytocel;Seque® San 3050

GUDID 06931132224009

Foshan United Medical Technologies Ltd.

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 06931132224009
• NIH Device Record Key: 91c8a0d5-1825-40d8-8dd1-b0c889cfc923
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kytocel;Seque® San
• Version Model Number: 5x5cm
• Catalog Number: 3050
• 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	06931132224009 [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: 2023-09-04
• Device Publish Date: 2023-08-25

Devices Manufactured by Foshan United Medical Technologies Ltd.

• 06931132201048 - Sequa® Cel: 2023-09-26
• 06931132201079 - Sequa® Cel: 2023-09-26 Sequa®Cel CMC Dressing is a sterile nonwoven wound dressing composed of 100% Carboxymethyl Cellulose (CMC) fibers. The Sequa®C
• 06931132201109 - Sequa® Cel: 2023-09-26 Sequa®Cel CMC Dressing is a sterile nonwoven wound dressing composed of 100% Carboxymethyl Cellulose (CMC) fibers. The Sequa®C
• 06931132203042 - Sequa® Sorb: 2023-09-26 Sequa®Sorb Alginate Wound Dressing is a sterile non-woven calcium/sodium alginate dressing consisting of a high gel strength al
• 06931132203073 - Sequa® Sorb: 2023-09-26 Sequa®Sorb Alginate Wound Dressing is a sterile non-woven calcium/sodium alginate dressing consisting of a high gel strength al
• 06931132203103 - Sequa® Sorb: 2023-09-26 Sequa®Sorb Alginate Wound Dressing is a sterile non-woven calcium/sodium alginate dressing consisting of a high gel strength al
• 06931132224030 - Kytocel: 2023-09-26
• 06931132224061 - Kytocel: 2023-09-26