ClearTip

GUDID 18809327352958

EUS-FNB 19G

FINEMEDIX CO.,LTD.

Flexible endoscopic biopsy handpiece/needle
Primary Device ID18809327352958
NIH Device Record Keyaa7f8ab8-619b-47d3-9cfb-8328869ef0a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearTip
Version Model NumberFM-CTB001
Company DUNS688256864
Company NameFINEMEDIX CO.,LTD.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82537418388
Emailfinemedix@finemedix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809327352951 [Primary]
GS118809327352958 [Package]
Contains: 08809327352951
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy Needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

On-Brand Devices [ClearTip]

18809327352972EUS-FNB 25G
18809327352965EUS-FNB 22G
18809327352958EUS-FNB 19G
18809327352941EUS-FNA 25G
18809327352934EUS-FNA 22G
18809327352927EUS-FNA 19G

Trademark Results [ClearTip]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARTIP
CLEARTIP
90536162 not registered Live/Pending
Yukon Medical, LLC
2021-02-19

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