SIENTRA Malar Implant 25-50DU

GUDID 00812790023318

Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 50 mm

Sientra, Inc.

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• Primary Device ID: 00812790023318
• NIH Device Record Key: dd45e566-9e01-47bc-bf31-da5159c591b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIENTRA Malar Implant
• Version Model Number: 25-50DU
• Catalog Number: 25-50DU
• Company DUNS: 010209877
• Company Name: Sientra, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com
• Phone: 888-708-0808
• Email: customer.experience@sientra.com

Device Dimensions

• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812790023318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981835

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: 2015-10-23

On-Brand Devices [SIENTRA Malar Implant]

• 00812790023349: Malar Implant, Solid Silicone, Anatomical, Smooth, Left, 50 mm
• 00812790023332: Malar Implant, Solid Silicone, Anatomical, Smooth, Left, 43 mm
• 00812790023325: Malar Implant, Solid Silicone, Anatomical, Smooth, Left, 40 mm
• 00812790023318: Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 50 mm
• 00812790023301: Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 43 mm
• 00812790023295: Malar Implant, Solid Silicone, Anatomical, Smooth, Right, 40 mm