Endoform Antimicrobial Dermal Template 629312

GUDID 09421904065604

Endoform Antimicrobial 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: 09421904065604
• NIH Device Record Key: ebfd497a-32d1-4d55-b81f-2826929ddea9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoform Antimicrobial Dermal Template
• Version Model Number: 629312
• Catalog Number: 629312
• 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: 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

• Length: 5 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *clean and dry area, away from direct light

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421904065444 [Primary]
GS1	09421904065543 [Package]; Contains: 09421904065444; Package: CARTON [10 Units]; In Commercial Distribution
GS1	09421904065604 [Package]; Contains: 09421904065543; Package: SHIPPER [100 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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-03-31

On-Brand Devices [Endoform Antimicrobial Dermal Template]

• 09421905067348: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac
• 09421905067379: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac
• 09421905067386: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac
• 09421904065611: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac
• 09421904065604: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac
• 09421904065598: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac
• 09421904065420: Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac