Precision Point Locator PPL01

GUDID 00819409020348

Precision Point Locator (5 each)

Sientra, Inc.

Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator Tissue expander injection port locator
Primary Device ID00819409020348
NIH Device Record Key5d3c089d-d8f9-45c5-a6f1-0e2b39e2b2fb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision Point Locator
Version Model NumberPPL01
Catalog NumberPPL01
Company DUNS010209877
Company NameSientra, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100819409020348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCJExpander, Skin, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-05
Device Publish Date2022-03-28

Devices Manufactured by Sientra, Inc.

00812790028191 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 230-280 cc
00812790028207 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 270-330 cc
00812790028214 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 360-430 cc
00812790028221 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 480-575 cc
00812790028238 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 600-720 cc
00812790028245 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Smooth Surface, Integrated Ports, Full Height, 750-900 cc
00812790028252 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Textured Surface, Integrated Ports, Full Height, 230-280 cc
00812790028269 - AlloX2 Tissue Expander2023-10-25 Tissue Expander, Textured Surface, Integrated Ports, Full Height, 270-330 cc
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