SIENTRA Calf Implant 402-190U

GUDID 00812790022939

Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 70 cc

Sientra, Inc.

Silicone-block tissue reconstructive material
Primary Device ID00812790022939
NIH Device Record Key51e1f308-7ed2-4ae4-b97d-088fbb164ab0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIENTRA Calf Implant
Version Model Number402-190U
Catalog Number402-190U
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
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
GS100812790022939 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

On-Brand Devices [SIENTRA Calf Implant]

00812790022953Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 105 cc
00812790022946Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 140 cc
00812790022939Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 70 cc
00812790022922Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 50 cc
00812790022915Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 30 cc
00812790022908Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 15 cc
00812790022892Calf Implant, Silicone Elastomer, Asymmetrical, Smooth, 175 cc
00812790022885Calf Implant, Silicone Elastomer, Asymmetrical, Smooth, 125 cc
00812790022878Calf Implant, Silicone Elastomer, Asymmetrical, Smooth, 70 cc

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