Endoform™ Natural Restorative Bioscaffold 529316

GUDID 09421906017342

Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.

AROA BIOSURGERY LIMITED

Collagen wound matrix dressing

• Primary Device ID: 09421906017342
• NIH Device Record Key: a3583c07-3248-4295-8e77-7dfa7228ca4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoform™ Natural Restorative Bioscaffold
• Version Model Number: 529316
• Catalog Number: 529316
• 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: false
• 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 Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Endoform Natural should be stored at room temperature in a clean and dry area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421906017236 [Primary]
GS1	09421906017342 [Package]; Contains: 09421906017236; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092096

FDA Product Code

• KGN: Dressing, Wound, Collagen

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™ Natural Restorative Bioscaffold]

• 09421906017410: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e
• 09421906017298: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e
• 09421906017397: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e
• 09421906017380: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e
• 09421906017373: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e
• 09421906017366: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e
• 09421906017359: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e
• 09421906017342: Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e