Chin Implant SCH 10-1

GUDID B049SCH1010

Sterile, silicone, chin implant.

HANSON MEDICAL

Chin prosthesis

• Primary Device ID: B049SCH1010
• NIH Device Record Key: b727ad28-cd6a-41dc-87a8-715e3120d0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chin Implant
• Version Model Number: SCH 10-1
• Catalog Number: SCH 10-1
• 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	B049SCH1010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090803

FDA Product Code

• FWP: Prosthesis, Chin, Internal

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: 2015-09-28

On-Brand Devices [Chin Implant]

• B049VCH5S0: Non-sterile, silicone, chin implant, sizer.
• B049VCH5F0: Non-sterile, silicone, chin implant.
• B049VCH50: Non-sterile, silicone, chin implant.
• B049VCH4S0: Non-sterile, silicone, chin implant, sizer.
• B049VCH4F0: Non-sterile, silicone, chin implant.
• B049VCH40: Non-sterile, silicone, chin implant.
• B049VCH3S0: Non-sterile, silicone, chin implant, sizer.
• B049VCH3F0: Non-sterile, silicone, chin implant.
• B049VCH30: Non-sterile, silicone, chin implant.
• B049VCH2S0: Non-sterile, silicone, chin implant, sizer.
• B049VCH2F0: Non-sterile, silicone, chin implant.
• B049VCH20: Non-sterile, silicone, chin implant.
• B049VCH1S0: Non-sterile, silicone, chin implant, sizer.
• B049VCH1F0: Non-sterile, silicone, chin implant.
• B049VCH10: Non-sterile, silicone, chin implant.
• B049SVCH5F0: Sterile, silicone, chin implant.
• B049SVCH50: Sterile, silicone, chin implant.
• B049SVCH4F0: Sterile, silicone, chin implant.
• B049SVCH40: Sterile, silicone, chin implant.
• B049SVCH3F0: Sterile, silicone, chin implant.
• B049SVCH30: Sterile, silicone, chin implant.
• B049SVCH2F0: Sterile, silicone, chin implant.
• B049SVCH20: Sterile, silicone, chin implant.
• B049SVCH1F0: Sterile, silicone, chin implant.
• B049SVCH10: Sterile, silicone, chin implant.
• B049SCH840: Sterile, silicone, chin implant.
• B049SCH830: Sterile, silicone, chin implant.
• B049SCH820: Sterile, silicone, chin implant.
• B049SCH810: Sterile, silicone, chin implant.
• B049SCH730: Sterile, silicone, chin implant.
• B049SCH720: Sterile, silicone, chin implant.
• B049SCH710: Sterile, silicone, chin implant.
• B049SCH630: Sterile, silicone, chin implant.
• B049SCH620: Sterile, silicone, chin implant.
• B049SCH610: Sterile, silicone, chin implant.
• B049SCH550: Sterile, silicone, chin implant.
• B049SCH540: Sterile, silicone, chin implant.
• B049SCH530: Sterile, silicone, chin implant.
• B049SCH520: Sterile, silicone, chin implant.
• B049SCH510: Sterile, silicone, chin implant.
• B049SCH440: Sterile, silicone, chin implant.
• B049SCH430: Sterile, silicone, chin implant.
• B049SCH420: Sterile, silicone, chin implant.
• B049SCH410: Sterile, silicone, chin implant.
• B049SCH340: Sterile, silicone, chin implant.
• B049SCH330: Sterile, silicone, chin implant.
• B049SCH320: Sterile, silicone, chin implant.
• B049SCH310: Sterile, silicone, chin implant.
• B049SCH240: Sterile, silicone, chin implant.
• B049SCH230: Sterile, silicone, chin implant.