Silicone Sizer Set for ePTFE Paranasal ESPN-SIZ-NS

GUDID M724ESPNSIZNS1

Silicone Sizer Set for ePTFE Paranasal

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis

• Primary Device ID: M724ESPNSIZNS1
• NIH Device Record Key: e99fd9ee-51f1-40ac-b8a9-9ac497409142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sizer Set for ePTFE Paranasal
• Version Model Number: ESPN-SIZ
• Catalog Number: ESPN-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	M724ESPNSIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141027

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

[M724ESPNSIZNS1]

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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