Sientra Viality-1400 Viality-1400

GUDID 00810076894621

Lipoaspirate Wash System

Sientra, Inc.

Autologous adipose tissue collection/washing set
Primary Device ID00810076894621
NIH Device Record Keyd00edca8-bd53-4647-bcb8-e0bef2b8759c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSientra Viality-1400
Version Model NumberViality-1400
Catalog NumberViality-1400
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810076894621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QKLLipoaspirate Washing System For Aesthetic Body Contouring

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-21
Device Publish Date2023-03-13

Devices Manufactured by Sientra, Inc.

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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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