Silicone Gel Sizer GSCBASE-365HP

GUDID 00819409024322

Silicone Gel Sizer, Smooth Shaped, Classic Base, High Projection, 365 cc

Sientra, Inc.

Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface Silicone gel-filled breast implant, textured-surface

• Primary Device ID: 00819409024322
• NIH Device Record Key: 8ad3581f-427e-4e79-b0ba-8c99648355ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Gel Sizer
• Version Model Number: GSCBASE-365HP
• Catalog Number: GSCBASE-365HP
• 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: true
• 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
• Phone: 888-708-0808
• Email: customer.experience@sientra.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00819409024322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070004

FDA Product Code

• FTR: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [Silicone Gel Sizer]

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• 00819409025763: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 650 cc
• 00819409025756: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 625 cc
• 00819409025749: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 595 cc
• 00819409025732: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 540 cc
• 00819409025725: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 500 cc
• 00819409025718: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 470 cc
• 00819409025701: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 445 cc
• 00819409025695: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 415 cc
• 00819409025688: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 390 cc
• 00819409025671: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 360 cc
• 00819409025664: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 340 cc
• 00819409025657: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 320 cc
• 00819409025640: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 300 cc
• 00819409025633: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 275 cc
• 00819409025626: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 260 cc
• 00819409025619: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 245 cc
• 00819409025602: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 220 cc
• 00819409025596: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 205 cc
• 00819409025589: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 190 cc
• 00819409025572: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 170 cc
• 00819409025565: Silicone Gel Sizer, Smooth Shaped, Round Base, Moderate Projection, 160 cc
• 00819409025480: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 550 cc
• 00819409025473: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 515 cc
• 00819409025466: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 485 cc
• 00819409025459: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 455 cc
• 00819409025442: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 425 cc
• 00819409025435: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 395 cc
• 00819409025428: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 370 cc
• 00819409025411: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 345 cc
• 00819409025404: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 320 cc
• 00819409025398: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 295 cc
• 00819409025381: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 270 cc
• 00819409025374: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 255 cc
• 00819409025367: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 235 cc
• 00819409025350: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 220 cc
• 00819409025343: Silicone Gel Sizer, Smooth Shaped, Round Base, High Projection, 200 cc
• 00819409025305: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 700 cc
• 00819409025299: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 650 cc
• 00819409025282: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 625 cc
• 00819409025275: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 600 cc
• 00819409025268: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 575 cc
• 00819409025251: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 550 cc
• 00819409025244: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 525 cc
• 00819409025237: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 500 cc
• 00819409025220: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 475 cc
• 00819409025213: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 450 cc
• 00819409025206: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 425 cc
• 00819409025190: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 400 cc
• 00819409025183: Silicone Gel Sizer, Smooth Shaped, Oval Base, Moderate Projection, 370 cc