Invia-Silverlon

GUDID 10857278000181

Wound Contact Negative Pressure Sheer Dressing 4in x 5in

ARGENTUM MEDICAL, LLC

Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set Negative-pressure wound therapy system dressing set

• Primary Device ID: 10857278000181
• NIH Device Record Key: 91298c46-4157-422d-b8f3-c58544ff1170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invia-Silverlon
• Version Model Number: 87.7001
• Company DUNS: 091449079
• Company Name: ARGENTUM MEDICAL, 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: true
• 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	00857278000184 [Primary]
GS1	10857278000181 [Package]; Contains: 00857278000184; Package: Inner box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141033

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-03
• Device Publish Date: 2018-11-30

On-Brand Devices [Invia-Silverlon]

• 10857278000181: Wound Contact Negative Pressure Sheer Dressing 4in x 5in
• 10857278000174: Wound Contact Negative Pressure Sheer Dressing 5in x 8in