OPUS Silicone Gel Breast Implant CBASE-180MP

GUDID 00819409021734

Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 180 cc

Sientra, Inc.

Silicone gel-filled breast implant, textured-surface
Primary Device ID00819409021734
NIH Device Record Key1025ae3b-b101-4c25-9b6a-582f4d7d3116
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPUS Silicone Gel Breast Implant
Version Model NumberCBASE-180MP
Catalog NumberCBASE-180MP
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
Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100819409021734 [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

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00819409021901Silicone Gel Breast Implant, Textured Shaped, Classic Base, Moderate Projection, 575 cc
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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

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