Endoform Myriad SR03LG1020US

GUDID 09421905067416

Myriad is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired.

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 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 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 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 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: 09421905067416
• NIH Device Record Key: 5a8bcafd-daed-47cc-9e5e-1ee2b1536eec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoform Myriad
• Version Model Number: MR03LG1020
• Catalog Number: SR03LG1020US
• Company DUNS: 594540572
• Company Name: AROA BIOSURGERY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• 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
• 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
• 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
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421904065673 [Previous]
GS1	09421905067416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162461

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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-03-31

On-Brand Devices [Endoform Myriad]

• 09421905067423: Myriad is intended for applications in plastic and reconstructive surgery or to cover, protect a
• 09421905067416: Myriad is intended for applications in plastic and reconstructive surgery or to cover, protect a
• 09421905067317: Myriad is intended for applications in plastic and reconstructive surgery or to cover, protect a
• 09421905067300: Myriad is intended for applications in plastic and reconstructive surgery or to cover, protect a