Perma Facial Implant

GUDID 00853437006042

Silicone soft tissue facial implant

SURGISIL, LLP

Malar prosthesis

• Primary Device ID: 00853437006042
• NIH Device Record Key: e979d552-00a3-4475-8b0b-22f2298f30e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perma Facial Implant
• Version Model Number: PFI 4060
• 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: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853437006042 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-10

On-Brand Devices [Perma Facial Implant]

• 00853437006080: silicone soft tissue facial implant
• 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..