Silicone Sizer Set for ePTFE Extended Chin ESEC-SIZ-NS

GUDID M724ESECSIZNS1

Silicone Sizer Set for ePTFE Extended Chin

IMPLANTECH ASSOCIATES, INC.

Chin prosthesis

• Primary Device ID: M724ESECSIZNS1
• NIH Device Record Key: 82aa5e9d-3a5e-454e-9dd5-b0be61561308
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sizer Set for ePTFE Extended Chin
• Version Model Number: ESEC-SIZ
• Catalog Number: ESEC-SIZ-NS
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724ESECSIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141027

FDA Product Code

• FWP: Prosthesis, Chin, Internal

Sterilization

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

[M724ESECSIZNS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-24
• Device Publish Date: 2019-06-14

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