Endoform Surface

GUDID 09421904065697

Endoform Surface 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 the surrounding tissue, if desired.

AROA BIOSURGERY LIMITED

Collagen wound matrix dressing

• Primary Device ID: 09421904065697
• NIH Device Record Key: 97d5aceb-d180-4602-a289-d4b58ecbb6f5
• Commercial Distribution Discontinuation: 2019-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Endoform Surface
• Version Model Number: SR05LG1020
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.com
• Phone: 877-627-6224
• Email: customerservice@aroabio.com
• Phone: 860-337-7730
• Email: customerservice@appulsemed.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 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
• 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	09421904065697 [Primary]
GS1	09421905067393 [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: 6
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-07-02

On-Brand Devices [Endoform Surface]

• 09421904065697: Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,
• 09421904065680: Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,
• 09421904065673: Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,
• 09421904065666: Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,