Silicone Gel Breast Implant OBASE-170LP

GUDID 00819409020621

Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 170 cc

Sientra, Inc.

Silicone gel-filled breast implant, textured-surface

• Primary Device ID: 00819409020621
• NIH Device Record Key: 91a19027-7787-4e88-97bf-6215869671ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Gel Breast Implant
• Version Model Number: OBASE-170LP
• Catalog Number: OBASE-170LP
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00819409020621 [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: 2023-06-20
• Device Publish Date: 2023-06-12

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• 00819409020560: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 625 cc
• 00819409020553: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 600 cc
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• 00819409020539: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 550 cc
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