OPUS Silicone Gel Breast Implant OBASE-350MP

GUDID 00819409020867

Silicone Gel Breast Implant, Textured Shaped, Oval Base, Moderate Projection, 350 cc

Sientra, Inc.

Silicone gel-filled breast implant, textured-surface
Primary Device ID00819409020867
NIH Device Record Key99e1c372-5e75-488c-b826-b264937ac7a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPUS Silicone Gel Breast Implant
Version Model NumberOBASE-350MP
Catalog NumberOBASE-350MP
Company DUNS010209877
Company NameSientra, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100819409020867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-25
Device Publish Date2020-10-05

On-Brand Devices [OPUS Silicone Gel Breast Implant]

00819409021949Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 700 cc
00819409021932Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 650 cc
00819409021925Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 625 cc
00819409021918Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 600 cc
00819409021901Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 575 cc
00819409021895Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 550 cc
00819409021888Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 525 cc
00819409021871Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 500 cc
00819409021864Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 475 cc
00819409021857Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 450 cc
00819409021840Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 425 cc
00819409021833Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 400 cc
00819409021826Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 375 cc
00819409021819Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 350 cc
00819409021802Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 335 cc
00819409021796Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 310 cc
00819409021789Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 295 cc
00819409021772Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 275 cc
00819409021765Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 260 cc
00819409021758Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 240 cc
00819409021741Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 210 cc
00819409021734Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 180 cc
00819409021161Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 515 cc
00819409021154Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 485 cc
00819409021147Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 455 cc
00819409021130Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 425 cc
00819409021123Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 395 cc
00819409021116Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 370 cc
00819409021109Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 345 cc
00819409021093Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 320 cc
00819409021086Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 295 cc
00819409021079Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 270 cc
00819409021062Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 255 cc
00819409021055Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 235 cc
00819409021048Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 220 cc
00819409021031Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 200 cc
00812790026227Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 700 cc
00812790026210Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 650 cc
00812790026203Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 600 cc
00812790026197Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 550 cc
00812790026180Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 510 cc
00812790026173Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 470 cc
00812790026166Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 440 cc
00812790026159Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 425 cc
00812790026142Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 410 cc
00812790026135Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 395 cc
00812790026128Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 380 cc
00812790026111Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 365 cc
00812790026104Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 350 cc
00812790026098Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 335 cc
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