Endoform™ Antimicrobial Restorative Bioscaffold 629313

GUDID 09421906017557

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 Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 09421906017557
• NIH Device Record Key: bf25852b-a34a-49d8-a673-1807cebba409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoform™ Antimicrobial Restorative Bioscaffold
• Version Model Number: 629313
• Catalog Number: 629313
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421906017489 [Primary]
GS1	09421906017557 [Package]; Contains: 09421906017489; 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