TRUCLEAR 72204064

GUDID 00885556584859

TRUCLEAR ULTRA MINI DEVICE

Smith & Nephew, Inc.

Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece, line-powered
Primary Device ID00885556584859
NIH Device Record Keye3773515-7a41-4986-827c-8241ae793063
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUCLEAR
Version Model Number72204064
Catalog Number72204064
Company DUNS109903521
Company NameSmith & Nephew, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556584859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-12-14

On-Brand Devices [TRUCLEAR]

00885556584859TRUCLEAR ULTRA MINI DEVICE
008855565836615C HYSTEROSCOPE SERVICE

Trademark Results [TRUCLEAR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUCLEAR
TRUCLEAR
97148479 not registered Live/Pending
TruClear Water Solutions, Inc.
2021-11-30
TRUCLEAR
TRUCLEAR
90904898 not registered Live/Pending
Ruchin Holdings, LLC
2021-08-26
TRUCLEAR
TRUCLEAR
88237400 not registered Live/Pending
Tastes Natural, LLC
2018-12-20
TRUCLEAR
TRUCLEAR
88151660 5811042 Live/Registered
Vision Source L.P.
2018-10-11
TRUCLEAR
TRUCLEAR
86374038 4973831 Live/Registered
ZODIAC POOL SYSTEMS LLC
2014-08-21
TRUCLEAR
TRUCLEAR
85409627 not registered Dead/Abandoned
Belkin International, Inc.
2011-08-29
TRUCLEAR
TRUCLEAR
85018725 not registered Dead/Abandoned
Teva Respiratory, LLC
2010-04-20
TRUCLEAR
TRUCLEAR
78523459 not registered Dead/Abandoned
QLT USA, Inc.
2004-11-29
TRUCLEAR
TRUCLEAR
77808763 3975189 Live/Registered
COVIDIEN LP
2009-08-20
TRUCLEAR
TRUCLEAR
77125908 3496554 Live/Registered
Vision Source L.P.
2007-03-08
TRUCLEAR
TRUCLEAR
74003198 1627874 Dead/Cancelled
ANALYTICAL DEVELOPMENT CORPORATION
1989-11-17

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