OPUS Silicone Gel Breast Implant RBASE-320MP

GUDID 00819409021345

Silicone Gel Breast Implant, Textured Shaped, Round Base, Moderate Projection, 320 cc

Sientra, Inc.

Silicone gel-filled breast implant, textured-surface
Primary Device ID00819409021345
NIH Device Record Key3c97deb3-de7a-47e0-8bce-486bb7e99495
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPUS Silicone Gel Breast Implant
Version Model NumberRBASE-320MP
Catalog NumberRBASE-320MP
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
GS100819409021345 [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 Date2020-05-11
Device Publish Date2020-05-01

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00819409021772Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 275 cc
00819409021765Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 260 cc
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00819409021130Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 425 cc
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00819409021116Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 370 cc
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00819409021062Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 255 cc
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00819409021048Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 220 cc
00819409021031Silicone Gel Breast Implant, Textured Shaped, Round Base, High Projection, 200 cc
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