Endoform Natural Dermal Template 529316

GUDID 09421905067324

Endoform Natural Dermal Template 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: 09421905067324
• NIH Device Record Key: 6e9113de-85d3-4e57-9eb4-fcff02271828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoform Natural Dermal Template
• 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: false
• 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

Device Dimensions

• Width: 5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421905067294 [Primary]
GS1	09421905067324 [Package]; Contains: 09421905067294; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-06-21

On-Brand Devices [Endoform Natural Dermal Template]

• 09421904065642: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
• 09421904065635: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
• 09421905067324: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
• 09421905067331: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
• 09421905067362: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
• 09421905067355: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
• 09421904065659: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula
• 09421904065628: Endoform Natural Dermal Template is a sterile, single use ovine forestomach-derived extracellula