ClearFit 171713

GUDID 00855113008036

Extra Large Static Cranial Implant (Primary and Backup

LONGEVITI NEURO SOLUTIONS LLC

Cranial resinous compound
Primary Device ID00855113008036
NIH Device Record Key752ade98-05f4-4c42-acab-85acbd9ba10f
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearFit
Version Model Number171713
Catalog Number171713
Company DUNS070659539
Company NameLONGEVITI NEURO SOLUTIONS LLC
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone410-527-1803
Emailinfo@longeviti.com

Device Dimensions

Area/Surface Area60 Square centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *See special handling instructions
Special Storage Condition, SpecifyBetween 0 and 0 *See special handling instructions
Special Storage Condition, SpecifyBetween 0 and 0 *See special handling instructions
Special Storage Condition, SpecifyBetween 0 and 0 *See special handling instructions

Device Identifiers

Device Issuing AgencyDevice ID
GS100855113008036 [Primary]
GS110855113008033 [Package]
Package: Case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-24
Device Publish Date2018-11-21

On-Brand Devices [ClearFit]

00855113008043Complex Static Cranial Implant (Primary and Backup)
00855113008036Extra Large Static Cranial Implant (Primary and Backup
00855113008029Large Static Cranial Implant (Primary and Backup)
00855113008012Medium Static Cranial Implant (Primary and Backup)
00855113008005Small Static Cranial Implant (Primary and Backup)
90855113008084Extra Small Flat
00855113008098Extra Small Curved
00855113008555ClearFit OTS Disc Curved X-Large
00855113008548ClearFit OTS Disc Curved Large
00855113008500ClearFit OTS 2.4cm Cover with Slot
00855113008494ClearFit OTS 2.4cm Cover
00855113008296ClearFit OTS Chiari Extra Small (22)
00855113008289ClearFit OTS Chiari Small (35)
00855113008272ClearFit OTS Chiari Small (22)
00855113008159ClearFit OTS Hemi Left
00855113008142ClearFit OTS Cover - 3cm
00855113008135ClearFit Hemi OTS Right
00855113008128ClearFit OTS Cover - 2cm with slot
00855113008111ClearFit OTS Cover - 2cm
00855113008104ClearFit VDI
00855113008623ClearFit Cover 2.1 (9mm thick)
00855113008562ClearFit Cover 2.0 (5.7mm thick)

Trademark Results [ClearFit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARFIT
CLEARFIT
97721113 not registered Live/Pending
Verathon, Inc.
2022-12-16
CLEARFIT
CLEARFIT
90687887 not registered Live/Pending
Mitsubishi Chemical Corporation
2021-05-03
CLEARFIT
CLEARFIT
88091166 not registered Live/Pending
Novartis AG
2018-08-24
CLEARFIT
CLEARFIT
87921378 5808119 Live/Registered
Longeviti Neuro Solutions LLC
2018-05-15
CLEARFIT
CLEARFIT
87818552 not registered Live/Pending
Clearfit Inc.
2018-03-02
CLEARFIT
CLEARFIT
86698908 5084739 Live/Registered
UNIRISE USA LLC
2015-07-20
CLEARFIT
CLEARFIT
85126245 3957606 Dead/Cancelled
UNIRISE USA, LLC
2010-09-09
CLEARFIT
CLEARFIT
79078596 3922165 Live/Registered
Mitsubishi Chemical Corporation
2009-12-28
CLEARFIT
CLEARFIT
77964269 4021126 Live/Registered
Clearfit Inc.
2010-03-21
CLEARFIT
CLEARFIT
77314398 3581393 Dead/Cancelled
TEAM IP HOLDINGS, LLC
2007-10-26
CLEARFIT
CLEARFIT
76284641 not registered Dead/Abandoned
SBH, Inc.
2001-07-13
CLEARFIT
CLEARFIT
72292710 0867523 Dead/Expired
QUICKFIT & QUARTZ LIMITED
1968-03-07

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