RENaSYS G LaRGE W/SOFT PORT 66800935

GUDID 30040565125733

RENASYS G GAUZE Dressing Kit with Soft Port Large

SMITH & NEPHEW MEDICAL LIMITED

Wound dressing kit, medicated, sterile

• Primary Device ID: 30040565125733
• NIH Device Record Key: 52da80da-6497-484a-978c-d7807b3985a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENaSYS G LaRGE W/SOFT PORT
• Version Model Number: 66800935
• Catalog Number: 66800935
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00040565125732 [Primary]
GS1	30040565125733 [Package]; Contains: 00040565125732; Package: case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162129

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [RENaSYS G LaRGE W/SOFT PORT]

• 30040565127218: RENASYS-G Gauze Dressing Kit with Soft Port Large
• 30040565125733: RENASYS G GAUZE Dressing Kit with Soft Port Large