OPUS Silicone Gel Breast Implant Sizer GS10621-435MP

GUDID 00819409023929

Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 435 cc

Sientra, Inc.

Invasive breast implant sizer, fixed, single-use

• Primary Device ID: 00819409023929
• NIH Device Record Key: 7478aaa3-d252-49d6-9f19-60d838a060a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPUS Silicone Gel Breast Implant Sizer
• Version Model Number: GS10621-435MP
• Catalog Number: GS10621-435MP
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00819409023929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200706

FDA Product Code

• MRD: Sizer, Mammary, Breast Implant Volume

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: 2021-01-19
• Device Publish Date: 2021-01-11

On-Brand Devices [OPUS Silicone Gel Breast Implant Sizer]

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• 00819409023608: Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 300 cc
• 00819409023950: Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 505 cc
• 00819409023929: Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 435 cc
• 00819409023905: Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 385 cc
• 00819409023868: Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 285 cc
• 00819409023684: Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 535 cc
• 00819409023646: Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 415 cc
• 00819409023639: Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 385 cc
• 00819409023592: Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 280 cc
• 00819409023585: Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 255 cc
• 00819409023554: Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 205 cc