Cellfina System Disposable Tray

GUDID 00840763100520

ULTHERA, INC.

Mechanical skin contouring system injection/transection set
Primary Device ID00840763100520
NIH Device Record Keyebdc083f-215b-4d60-b931-5a597e78ce2f
Commercial Distribution Discontinuation2019-07-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCellfina System Disposable Tray
Version Model NumberCK1 rev E
Company DUNS010981554
Company NameULTHERA, 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840763100520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-26
Device Publish Date2019-07-18

On-Brand Devices [Cellfina System Disposable Tray]

00840763100766CK1 rev M
00840763100612CK1 Rev K
00840763100520CK1 rev E
00840763100414CK1 Rev J
00840763100407CK1 Rev. I
00840763100391CK1 Rev. G
00840763100094CK1 Rev. F

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