White PVA Foam Large

GUDID 00849405035138

The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing

• Primary Device ID: 00849405035138
• NIH Device Record Key: c0316234-28a3-439d-b1d0-62d0dfe58fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: White PVA Foam Large
• Version Model Number: XF-PVALFOAM1
• Company DUNS: 006616130
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Depth: 1 Centimeter
• Depth: 1 Centimeter
• Depth: 1 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849405035138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142646

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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