RENCURA RCCS44

GUDID 30665973032239

Calcium Alginate Dressing with Silver 4X4

Dukal LLC

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 30665973032239
• NIH Device Record Key: 46dd71ef-b448-4497-a198-e41d3cc23283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENCURA
• Version Model Number: RCCS44
• Catalog Number: RCCS44
• Company DUNS: 791014871
• Company Name: Dukal LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10665973032235 [Primary]
GS1	20665973032232 [Package]; Contains: 10665973032235; Package: Box [10 Units]; In Commercial Distribution
GS1	30665973032239 [Package]; Contains: 20665973032232; Package: Case [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: 2024-11-12
• Device Publish Date: 2024-11-04

On-Brand Devices [RENCURA]

• 30665973032062: Silicone Bordered Foam Dressing 5"x5"
• 20665973032041: Silicone Bordered Foam Sacral Dressing 9.2"x9.2"
• 30665973032031: Silicone Bordered Foam Sacral Dressing 7.2"x7.2"
• 20665973032027: Silicone Bordered Foam Dressing 6"x6"
• 30665973032017: Silicone Bordered Foam Dressing 4"x4"
• 20665973032003: Silicone Bordered Foam Dressing, 3"x3"
• 30665973032260: Calcium Alginate Dressing with Silver 1X12 Rope
• 20665973032256: Calcium Alginate Dressing with Silver 4X8
• 30665973032246: Calcium Alginate Dressing with Silver 6X6
• 30665973032239: Calcium Alginate Dressing with Silver 4X4
• 20665973032225: Calcium Alginate Dressing with Silver 2X2
• 30665973032215: Calcium Alginate Dressing 1X12 Rope
• 30665973032208: Calcium Alginate Dressing 4X8
• 20665973032195: Calcium Alginate Dressing 6x6
• 20665973032188: Calcium Alginate Dressing 4X4
• 20665973032171: Calcium Alginate Dressing 2X2