Pectoralis Implant ACP 2-1 R S

GUDID B049ACP21RS0

Non-sterile, silicone, pectoralis implant, right, sizer.

HANSON MEDICAL

Pectoral implant, non-sterile

• Primary Device ID: B049ACP21RS0
• NIH Device Record Key: a43047bc-6fb4-42f2-80c9-054ef261f2b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pectoralis Implant
• Version Model Number: ACP 2-1 R S
• Catalog Number: ACP 2-1 R 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	B049ACP21RS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973729

FDA Product Code

• MIC: Implant, Muscle, Pectoralis

Sterilization

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

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

[B049ACP21RS0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-14

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• B049ACP31L0: Non-sterile, silicone, pectoralis implant, left.
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• B049ACP24R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP24LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP24L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP240: Non-sterile, silicone, pectoralis implant, pair.
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• B049ACP220: Non-sterile, silicone, pectoralis implant, pair.
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• B049ACP21R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP21LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP21L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP210: Non-sterile, silicone, pectoralis implant, pair.
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• B049ACP14R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP14LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
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• B049ACP140: Non-sterile, silicone, pectoralis implant, pair.
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• B049ACP13R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP13LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP13L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP130: Non-sterile, silicone, pectoralis implant, pair.
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• B049ACP12R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP12LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP12L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP120: Non-sterile, silicone, pectoralis implant, pair.
• B049ACP11RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• B049ACP11R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP11LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
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