OPUS Silicone Gel Breast Implant CBASE-210MP

GUDID 00819409021741

Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 210 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
Primary Device ID00819409021741
NIH Device Record Key5db1fdb5-c139-4a0f-9b10-68023938d7fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPUS Silicone Gel Breast Implant
Version Model NumberCBASE-210MP
Catalog NumberCBASE-210MP
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
Phone888-708-0808
Emailcustomer.experience@sientra.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100819409021741 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [OPUS Silicone Gel Breast Implant]

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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
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00819409021840Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 425 cc
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00819409021819Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 350 cc
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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
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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
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00812790026180Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 510 cc
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00812790026135Silicone Gel Breast Implant, Smooth Round, Moderate Projection, 395 cc
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