Composite Nasal Implant ePTFE-VSDC-W5030

GUDID M724EPTFEVSDCW50301

Nasal Implant

IMPLANTECH ASSOCIATES, INC.

Nasal implant, synthetic polymer, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable

• Primary Device ID: M724EPTFEVSDCW50301
• NIH Device Record Key: 682a219c-b7ab-4cfb-af62-053f6e079d62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Composite Nasal Implant
• Version Model Number: ePTFE-VSDC-W5030
• Catalog Number: ePTFE-VSDC-W5030
• Company DUNS: 784664955
• Company Name: IMPLANTECH ASSOCIATES, INC.
• 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: 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: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724EPTFEVSDCW50301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002886

FDA Product Code

• LZK: Implant, Malar

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: 2019-11-14
• Device Publish Date: 2017-07-10

On-Brand Devices [Composite Nasal Implant]

• M724EPTFEVSDCW55451: Nasal Implant
• M724EPTFEVSDCW50501: Nasal Implant
• M724EPTFEVSDCW50351: Nasal Implant
• M724EPTFEVSDCW50301: Nasal Implant
• M724EPTFEVSDCW50201: Nasal Implant
• M724EPTFEVSDCN47501: Nasal Implant
• M724EPTFEVSDCN47401: Nasal Implant
• M724EPTFEVSDCN47301: Nasal Implant