Hybrid Dressing - Revo Unsterile

GUDID 10849405002830

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing, non-antimicrobial

• Primary Device ID: 10849405002830
• NIH Device Record Key: cbebd946-22c5-4f03-af6b-390a2ee9ab39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybrid Dressing - Revo Unsterile
• Version Model Number: HFD-D1520-UNS
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849405002833 [Primary]
GS1	10849405002830 [Package]; Contains: 00849405002833; Package: Case [10 Units]; In Commercial Distribution

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: 2026-03-24
• Device Publish Date: 2026-03-16

On-Brand Devices [Hybrid Dressing - Revo Unsterile]

• 10849405002847: HFD-D1020-UNS
• 10849405002830: HFD-D1520-UNS
• 10849405002823: HFD-D1530-UNS
• 10849405002816: HFD-D1030-UNS
• 10849405002809: HFD-D1050-UNS
• 10849405002793: HFD-D1040-UNS