RENaSYS G XL W/SOFT PORT 66800936

GUDID 30040565125740

RENASYS G GAUZE Dressing Kit with Soft Port X-Large

SMITH & NEPHEW MEDICAL LIMITED

Wound dressing kit, medicated, sterile

• Primary Device ID: 30040565125740
• NIH Device Record Key: fa14968b-7e44-4251-9535-745630f55db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENaSYS G XL W/SOFT PORT
• Version Model Number: 66800936
• Catalog Number: 66800936
• 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	00040565125749 [Primary]
GS1	30040565125740 [Package]; Contains: 00040565125749; 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

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