900-010 Anatomical Malar I Sizer Set 900-010

GUDID M7249000101

Malar Sizer Set

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis

• Primary Device ID: M7249000101
• NIH Device Record Key: bec406d0-dd27-4cdd-a78a-13ad6f8693c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 900-010 Anatomical Malar I Sizer Set
• Version Model Number: 900-010
• Catalog Number: 900-010
• 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
• 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	M7249000101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944165

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

[M7249000101]

Moist Heat or Steam Sterilization

[M7249000101]

Moist Heat or Steam Sterilization

[M7249000101]

Moist Heat or Steam Sterilization

[M7249000101]

Moist Heat or Steam Sterilization

[M7249000101]

Moist Heat or Steam Sterilization

[M7249000101]

Moist Heat or Steam Sterilization

[M7249000101]

Moist Heat or Steam Sterilization

[M7249000101]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-28
• Device Publish Date: 2021-07-20

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