Perma Facial Implant

GUDID 00853437006011

Silicone soft tissue facial implant..

SURGISIL, LLP

Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis Lip prosthesis

• Primary Device ID: 00853437006011
• NIH Device Record Key: cc54c4e6-0772-4458-a27d-e6812d587e07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perma Facial Implant
• Version Model Number: PFI 3060
• Company DUNS: 010030665
• Company Name: SURGISIL, LLP
• 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: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com
• Phone: 972-543-2497
• Email: mikeal@surgisil.com

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853437006011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071823

FDA Product Code

• ODU: Facial Implant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-27

On-Brand Devices [Perma Facial Implant]

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• 00853437006073: silicone soft tissue facial implant
• 00853437006066: silicone soft tissue facial implant
• 00853437006059: silicone soft tissue facial implant..
• 00853437006042: Silicone soft tissue facial implant
• 00853437006035: Silicone soft tissue facial implant
• 00853437006028: Silicone soft tissue facial implant..
• 00853437006011: Silicone soft tissue facial implant..
• 00853437006004: Silicone soft tissue facial implant..