Malar Implant SM 4-3

GUDID B049SM430

Sterile, silicone, malar implant, pair.

HANSON MEDICAL

Malar prosthesis

• Primary Device ID: B049SM430
• NIH Device Record Key: afb06502-6ca5-4c39-8829-acf5cade6752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Malar Implant
• Version Model Number: SM 4-3
• Catalog Number: SM 4-3
• 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: 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)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	B049SM430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090803

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-08

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• B049SM430: Sterile, silicone, malar implant, pair.
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• B049SM230: Sterile, silicone, malar implant, pair.
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• B049SM210: Sterile, silicone, malar implant, pair.
• B049SM130: Sterile, silicone, malar implant, pair.
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• B049SM1230: Sterile, silicone, malar implant, pair.
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• B049SM1010: Sterile, silicone, malar implant, pair.
• B049M93S0: Non-sterile, silicone, malar implant, sizer, pair.
• B049M930: Non-sterile, silicone, malar implant, pair.
• B049M92S0: Non-sterile, silicone, malar implant, sizer, pair.
• B049M920: Non-sterile, silicone, malar implant, pair.
• B049M91S0: Non-sterile, silicone, malar implant, sizer, pair.
• B049M910: Non-sterile, silicone, malar implant, pair.
• B049M83S0: Non-sterile, silicone, malar implant, sizer, pair.
• B049M830: Non-sterile, silicone, malar implant, pair.
• B049M82S0: Non-sterile, silicone, malar implant, sizer, pair.
• B049M820: Non-sterile, silicone, malar implant, pair.
• B049M81S0: Non-sterile, silicone, malar implant, sizer, pair.
• B049M810: Non-sterile, silicone, malar implant, pair.