SIENTRA Pectoral Implant 20132-160DU

GUDID 00812790023141

Pectoral Implant, Silicone Elastomer, Textured, Right, 230 cc

Sientra, Inc.

Pectoral implant, sterile
Primary Device ID00812790023141
NIH Device Record Key3798c9f1-1482-4195-b75d-66feb26f8c3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIENTRA Pectoral Implant
Version Model Number20132-160DU
Catalog Number20132-160DU
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
GS100812790023141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-10-23

On-Brand Devices [SIENTRA Pectoral Implant]

00812790023189Pectoral Implant, Silicone Elastomer, Textured, Left, 300 cc
00812790023172Pectoral Implant, Silicone Elastomer, Textured, Left, 230 cc
00812790023165Pectoral Implant, Silicone Elastomer, Textured, Left, 190 cc
00812790023158Pectoral Implant, Silicone Elastomer, Textured, Right, 300 cc
00812790023141Pectoral Implant, Silicone Elastomer, Textured, Right, 230 cc
00812790023134Pectoral Implant, Silicone Elastomer, Textured, Right, 190 cc

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