Spiro Foam Dressing

GUDID 00849405031321

Genadyne Spiro Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing

• Primary Device ID: 00849405031321
• NIH Device Record Key: 8ee2ab61-2a78-4294-ae63-b0171687f0bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiro Foam Dressing
• Version Model Number: XF-SPMF1
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00849405031321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141961

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: 2016-09-27

Devices Manufactured by GENADYNE BIOTECHNOLOGIES INC.

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• 00849405000549 - UNO 7 Therapy Kit 10x10: 2023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The