OPUS Silicone Gel Breast Implant Sizer GS10621-280HP

GUDID 00819409023592

Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 280 cc

Sientra, Inc.

Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use
Primary Device ID00819409023592
NIH Device Record Keyc08d4931-1d7a-462f-b92b-0acb8e404a18
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPUS Silicone Gel Breast Implant Sizer
Version Model NumberGS10621-280HP
Catalog NumberGS10621-280HP
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
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100819409023592 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRDSizer, Mammary, Breast Implant Volume

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-19
Device Publish Date2021-01-11

On-Brand Devices [OPUS Silicone Gel Breast Implant Sizer]

00819409023615Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 330 cc
00819409023608Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 300 cc
00819409023950Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 505 cc
00819409023929Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 435 cc
00819409023905Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 385 cc
00819409023868Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 285 cc
00819409023684Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 535 cc
00819409023646Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 415 cc
00819409023639Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 385 cc
00819409023592Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 280 cc
00819409023585Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 255 cc
00819409023554Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 205 cc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.