Voloshin Dorsal Columella 400-654S

GUDID M724400654S1

Nasal Implant

IMPLANTECH ASSOCIATES, INC.

Nasal implant, synthetic polymer, non-bioabsorbable

• Primary Device ID: M724400654S1
• NIH Device Record Key: 7ddd83e6-78f1-4913-993b-91930a1bb5c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Voloshin Dorsal Columella
• Version Model Number: Size 5
• Catalog Number: 400-654S
• 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
• 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	M724400654S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944166

FDA Product Code

• FZE: Prosthesis, Nose, Internal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-22
• Device Publish Date: 2021-04-14

On-Brand Devices [Voloshin Dorsal Columella ]

• M724VSDC0101: Nasal Implant
• M724VSDC0041: Nasal Implant
• M724VSDC0031: Nasal Implant
• M724VSDC0021: Nasal Implant
• M724VSDC0011: Nasal Implant
• M724400664S1: Nasal Implant
• M724400654S1: Nasal Implant
• M724400644S1: Nasal Implant
• M724400634S1: Nasal Implant
• M724400624S1: Nasal Implant
• M724400614S1: Nasal Implant
• M724VSDC010NS1: Nasal Implant
• M724VSDC004NS1: Nasal Implant
• M724VSDC003NS1: Nasal Implant
• M724VSDC002NS1: Nasal Implant
• M724VSDC001NS1: Nasal Implant