SU-POR Surgical Imnplant 4037

GUDID 00815285020366

Quadro-Port Tunnel Orbital Sphere 18mm

PORIFEROUS, LLC

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 00815285020366
• NIH Device Record Key: e7377f2a-5c64-4c4e-aac6-427678c9ed68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SU-POR Surgical Imnplant
• Version Model Number: 4037
• Catalog Number: 4037
• Company DUNS: 078388975
• Company Name: PORIFEROUS, LLC
• 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: true
• 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: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com
• Phone: 770-683-3855
• Email: info@poriferous.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815285020366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140437

FDA Product Code

• FWP: Prosthesis, Chin, Internal

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: 2016-03-01

Devices Manufactured by PORIFEROUS, LLC

• 00815285024777 - SU-POR Surgical Implant: 2024-12-19 Tah-Ear-I - Medium - Left
• 00815285024784 - SU-POR Surgical Implant: 2024-12-19 Tah-Ear-I - Medium - Right
• 00815285024791 - SU-POR Surgical Implant: 2024-12-19 Tah-Ear-I - Small - Left
• 00815285024807 - SU-POR Surgical Implant: 2024-12-19 Tah-Ear-I - Small - Right
• 00815285024814 - SU-POR Surgical Implant: 2024-12-19 Tah-Ear-I - Large - Left
• 00815285024821 - SU-POR Surgical Implant: 2024-12-19 Tah-Ear-I - Large - Right
• 00815285024364 - SU-POR Surgical Implant: 2024-11-15 Patient-Specific Ear - CHINA
• 00081528502436 - SU-POR Surgical Implant: 2024-10-24 Patient-Specific Ear - CHINA