Pectoralis Implant ACP 3-1 L S

GUDID B049ACP31LS0

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

HANSON MEDICAL

Pectoral implant, non-sterile

• Primary Device ID: B049ACP31LS0
• NIH Device Record Key: d8c57f25-c4e5-484e-b98f-50d1ef60e384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pectoralis Implant
• Version Model Number: ACP 3-1 L S
• Catalog Number: ACP 3-1 L 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	B049ACP31LS0 [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

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

Moist Heat or Steam Sterilization

[B049ACP31LS0]

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

On-Brand Devices [Pectoralis Implant]

• B049ACP31RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• B049ACP31R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP31LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP31L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP310: Non-sterile, silicone, pectoralis implant, pair.
• B049ACP24RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• 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.
• B049ACP23RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• B049ACP23R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP23LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP23L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP230: Non-sterile, silicone, pectoralis implant, pair.
• B049ACP22RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• B049ACP22R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP22LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP22L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP220: Non-sterile, silicone, pectoralis implant, pair.
• B049ACP21RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• 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.
• B049ACP14RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• B049ACP14R0: Non-sterile, silicone, pectoralis implant, right.
• B049ACP14LS0: Non-sterile, silicone, pectoralis implant, left, sizer.
• B049ACP14L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP140: Non-sterile, silicone, pectoralis implant, pair.
• B049ACP13RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• 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.
• B049ACP12RS0: Non-sterile, silicone, pectoralis implant, right, sizer.
• 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.
• B049ACP11L0: Non-sterile, silicone, pectoralis implant, left.
• B049ACP110: Non-sterile, silicone, pectoralis implant, pair.