Malar Implant M 7-2 S

GUDID B049M72S0

Non-sterile, silicone, malar implant, sizer, pair.

HANSON MEDICAL

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

• Primary Device ID: B049M72S0
• NIH Device Record Key: 126fc009-45ba-40d0-aac3-6089f578afe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Malar Implant
• Version Model Number: M 7-2 S
• Catalog Number: M 7-2 S
• Company DUNS: 058759296
• Company Name: HANSON MEDICAL
• 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: false
• 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)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B049M72S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973574

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

[B049M72S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-12

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