Endoform™ Antimicrobial Restorative Bioscaffold 629315

GUDID 09421906017533

Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment and contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, intended to inhibit colonization of the device.

AROA BIOSURGERY LIMITED

Collagen wound matrix dressing

• Primary Device ID: 09421906017533
• NIH Device Record Key: 4ddd0f05-62c5-4991-8683-ea4516c35830
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoform™ Antimicrobial Restorative Bioscaffold
• Version Model Number: 629315
• Catalog Number: 629315
• Company DUNS: 594540572
• Company Name: AROA BIOSURGERY LIMITED
• 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: true
• 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

Customer Support Contacts

• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421906017465 [Primary]
GS1	09421906017533 [Package]; Contains: 09421906017465; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172318

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-30
• Device Publish Date: 2021-08-20

On-Brand Devices [Endoform™ Antimicrobial Restorative Bioscaffold]

• 09421906017571: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-der
• 09421906017564: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-der
• 09421906017557: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-der
• 09421906017540: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-der
• 09421906017533: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-der
• 09421906017588: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-der
• 09421906017427: Endoform™ Antimicrobial Restorative Bioscaffold is a sterile, single use ovine forestomach-der