SIENTRA Silicone Gel Breast Implant 20646-200RB

GUDID 00812790021888

Silicone Gel Breast Implant, Textured Shaped Round Base, 200 cc

Sientra, Inc.

Silicone gel-filled breast implant
Primary Device ID00812790021888
NIH Device Record Key334a72cd-8f6e-4a6e-aba5-9a984f9221a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIENTRA Silicone Gel Breast Implant
Version Model Number20646-200RB
Catalog Number20646-200RB
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 Latexfalse
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
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
GS100812790021888 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

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00812790025589Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 255cc
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00812790025565Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 215cc
00812790025558Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 195cc
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00812790025534Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 155cc
00812790025527Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 135cc
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00812790025503Silicone Gel Breast Implant, Textured Round, Moderate Plus Profile, 95cc
00812790025497Silicone Gel Breast Implant, Textured Round, High Profile, 700 cc
00812790025473Silicone Gel Breast Implant, Textured Round, High Profile, 620 cc
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