Gluteal Implant ACP 5-2

GUDID B049ACP520

Non-sterile, silicone, gluteal implant, pair.

HANSON MEDICAL

Silicone-block tissue reconstructive material

• Primary Device ID: B049ACP520
• NIH Device Record Key: c930756a-e696-40d2-ac93-80e7305e7e21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gluteal Implant
• Version Model Number: ACP 5-2
• Catalog Number: ACP 5-2
• 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	B049ACP520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030809

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

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

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

Moist Heat or Steam Sterilization

[B049ACP520]

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

On-Brand Devices [Gluteal Implant]

• B049ACP91S0: Non-sterile, silicone, gluteal implant, sizer.
• B049ACP91R0: Non-sterile, silicone, gluteal implant, right.
• B049ACP91L0: Non-sterile, silicone, gluteal implant, left.
• B049ACP910: Non-sterile, silicone, gluteal implant, pair.
• B049ACP61S0: Non-sterile, silicone, gluteal implant, sizer.
• B049ACP61R0: Non-sterile, silicone, gluteal implant, right.
• B049ACP61L0: Non-sterile, silicone, gluteal implant, left.
• B049ACP610: Non-sterile, silicone, gluteal implant, pair.
• B049ACP52S0: Non-sterile, silicone, gluteal implant, sizer.
• B049ACP52R0: Non-sterile, silicone, gluteal implant, right.
• B049ACP52L0: Non-sterile, silicone, gluteal implant, left.
• B049ACP520: Non-sterile, silicone, gluteal implant, pair.
• B049ACP51S0: Non-sterile, silicone, gluteal implant, sizer.
• B049ACP51R0: Non-sterile, silicone, gluteal implant, right.
• B049ACP51L0: Non-sterile, silicone, gluteal implant, left.
• B049ACP510: Non-sterile, silicone, gluteal implant, pair.
• B049ACP42RS0: Non-sterile, silicone, gluteal implant, right, sizer.
• B049ACP42R0: Non-sterile, silicone, gluteal implant, right.
• B049ACP42LS0: Non-sterile, silicone, gluteal implant, left, sizer.
• B049ACP42L0: Non-sterile, silicone, gluteal implant, left.
• B049ACP420: Non-sterile, silicone, gluteal implant, pair.
• B049ACP41S0: Non-sterile, silicone, gluteal implant, sizer.
• B049ACP41R0: Non-sterile, silicone, gluteal implant, right.
• B049ACP41L0: Non-sterile, silicone, gluteal implant, left.
• B049ACP410: Non-sterile, silicone, gluteal implant, pair.