Hyalo4 Care Clear Hydrogel, 30g 49429-0030-10

GUDID M713494290030100

Clear hydrogel wound dressing, 30g, Professional Sample

FIDIA FARMACEUTICI SPA

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: M713494290030100
• NIH Device Record Key: 12742ecb-ffbc-4a70-8625-0550e26b0d9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyalo4 Care Clear Hydrogel, 30g
• Version Model Number: 49429-0030-10
• Catalog Number: 49429-0030-10
• Company DUNS: 428453013
• Company Name: FIDIA FARMACEUTICI SPA
• 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: false
• 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

Customer Support Contacts

• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us
• Phone: 9735776202
• Email: regulatory@fidiapharma.us

Operating and Storage Conditions

• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M713494290030100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973725

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by FIDIA FARMACEUTICI SPA

• M713891220724200 - Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL: 2023-10-24 Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the
• M713891220724120 - Hyalgan® Sodium Hyaluronate 2mL Vial: 2023-09-21 Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the kne
• M713494290030100 - Hyalo4 Care Clear Hydrogel, 30g: 2023-06-22Clear hydrogel wound dressing, 30g, Professional Sample
• M713494290030100 - Hyalo4 Care Clear Hydrogel, 30g: 2023-06-22 Clear hydrogel wound dressing, 30g, Professional Sample
• M713494290100350 - Hyalo4 Care Clear Hydrogel, 100g: 2023-06-22 Clear hydrogel wound dressing, 100g Tube
• M713494440025080 - Hyalo4 Care Hydrogel, 25g: 2023-06-22 Hydrogel wound dressing, 25g, Professional Sample
• M713494440100350 - Hyalo4 Care Hydrogel, 100g: 2023-06-22 Hydrogel wound dressing, 100g Tube
• M713891220496010 - Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack: 2022-10-04 HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and resi
• M71389122049663SAM1 - Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe: 2022-09-16 HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and resi