Tissue Expander Remote Port Accessories RPA01

GUDID 00819409020362

Tissue Expander Remote Port Accessories

Sientra, Inc.

Tissue expander injection port locator
Primary Device ID00819409020362
NIH Device Record Keyaae3acb5-39ee-418c-9a18-ea8c730e1df4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissue Expander Remote Port Accessories
Version Model NumberRPA01
Catalog NumberRPA01
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 Kittrue
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
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819409020362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCJTissue Expander And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-22
Device Publish Date2023-08-14

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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