Silicone Gel Breast Implant OBASE-600LP

GUDID 00819409020706

Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 600 cc

Sientra, Inc.

Silicone gel-filled breast implant, textured-surface

• Primary Device ID: 00819409020706
• NIH Device Record Key: c8b9e390-4e03-428d-b599-0f60a726a40a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Gel Breast Implant
• Version Model Number: OBASE-600LP
• Catalog Number: OBASE-600LP
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819409020706 [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 Breast Implant]

• 00819409020782: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 180 cc
• 00819409020775: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 150 cc
• 00819409020768: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 120 cc
• 00819409020621: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 170 cc
• 00819409020423: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 180 cc
• 00819409021178: Silicone Gel Breast Implant, Textured Shaped Round Base, High Projection, 550 cc
• 00819409020997: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 700 cc
• 00819409020980: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 650 cc
• 00819409020973: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 625 cc
• 00819409020966: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 600 cc
• 00819409020959: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 575 cc
• 00819409020942: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 550 cc
• 00819409020935: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 525 cc
• 00819409020928: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 500 cc
• 00819409020911: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 475 cc
• 00819409020904: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 450 cc
• 00819409020898: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 425 cc
• 00819409020881: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 400 cc
• 00819409020874: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 370 cc
• 00819409020850: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 330 cc
• 00819409020836: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 290 cc
• 00819409020812: Silicone Gel Breast Implant, Textured Shaped Oval Base, Moderate Projection, 250 cc
• 00819409020720: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 700 cc
• 00819409020713: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 650 cc
• 00819409020706: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 600 cc
• 00819409020690: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 550 cc
• 00819409020683: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 500 cc
• 00819409020676: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 450 cc
• 00819409020669: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 410 cc
• 00819409020652: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 320 cc
• 00819409020645: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 270 cc
• 00819409020638: Silicone Gel Breast Implant, Textured Shaped Oval Base, Low Projection, 220 cc
• 00819409020577: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 650 cc
• 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
• 00819409020546: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 575 cc
• 00819409020539: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 550 cc
• 00819409020522: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 510 cc
• 00819409020515: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 480 cc
• 00819409020508: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 440 cc
• 00819409020492: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 400 cc
• 00819409020485: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 370 cc
• 00819409020478: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 335 cc
• 00819409020461: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 300 cc
• 00819409020454: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 270 cc
• 00819409020447: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 240 cc
• 00819409020430: Silicone Gel Breast Implant, Textured Shaped Oval Base, High Projection, 210 cc