Hyalo4 Care Hydrogel, 100g 49444-0100-35

GUDID M713494440100350

Hydrogel wound dressing, 100g Tube

FIDIA FARMACEUTICI SPA

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: M713494440100350
• NIH Device Record Key: d0b0dec8-1703-460f-bd1e-809abbfbf067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyalo4 Care Hydrogel, 100g
• Version Model Number: 49444-0100-35
• Catalog Number: 49444-0100-35
• 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	M713494440100350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963004

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

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