Softouch® 1628-096

GUDID 10884450283315

Merit Medical Systems, Inc.

Angiographic catheter, single-use

Primary Device ID	10884450283315
NIH Device Record Key	68854199-e550-481c-9fd0-c745709c8f23
Commercial Distribution Status	In Commercial Distribution
Brand Name	Softouch®
Version Model Number	00884450283318
Catalog Number	1628-096
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450283318 [Primary]
GS1	10884450283315 [Package] Contains: 00884450283318 Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K943739

FDA Product Code

DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

On-Brand Devices [Softouch®]

10884450294540	00884450294543
10884450294502	00884450294505
10884450283322	00884450283325
10884450283315	00884450283318
10884450283285	00884450283288
10884450283261	00884450283264
10884450283124	00884450283127
10884450251185	00884450251188
10884450251178	00884450251171
10884450251147	00884450251140
10884450232498	00884450232491
10884450207670	00884450207673
10884450207144	00884450207147
10884450207120	00884450207123
10884450168131	00884450168134
10884450145729	00884450145722
10884450122850	00884450122853
10884450082628	00884450082621
10884450082598	00884450082591
10884450076030	00884450076033
10884450073435	00884450073438
10884450073428	00884450073421
10884450067618	00884450067611
10884450066550	00884450066553
10884450066420	00884450066423
10884450066413	00884450066416
10884450066406	00884450066409
10884450066352	00884450066355
10884450063320	00884450063323
10884450063290	00884450063293
10884450063276	00884450063279
10884450062156	00884450062159
10884450040604	00884450040607
10884450040451	00884450040454
10884450040444	00884450040447
10884450040437	00884450040430
10884450040406	00884450040409
10884450040390	00884450040393
10884450026509	00884450026502
10884450010140	00884450010143
10884450003104	00884450003107
10884450003098	00884450003091
10884450003081	00884450003084

Trademark Results [Softouch]

Mark Image Registration \| Serial	Company Trademark Application Date
SOFTOUCH 97397884 not registered Live/Pending	Kimberly-Clark Worldwide, Inc. 2022-05-06
SOFTOUCH 90902590 not registered Live/Pending	KOPEX USA INC 2021-08-25
SOFTOUCH 90530467 not registered Live/Pending	Schneller LLC 2021-02-16
SOFTOUCH 86947770 5510690 Live/Registered	Kama Global LLC 2016-03-21
SOFTOUCH 86554684 4831407 Live/Registered	Marlen Textiles, Inc. 2015-03-05
SOFTOUCH 86274923 not registered Dead/Abandoned	Marlen Textiles, Inc. 2014-05-07
SOFTOUCH 85616570 not registered Dead/Abandoned	NextInput Inc. 2012-05-04
SOFTOUCH 85615309 not registered Dead/Abandoned	Top-Line Armor Systems, LLC 2012-05-03
SOFTOUCH 85615308 4393433 Live/Registered	Top-Line Armor Systems, LLC 2012-05-03
SOFTOUCH 85487702 not registered Dead/Abandoned	kch corp ( a ny corp ) 2011-12-05
SOFTOUCH 85415354 4518136 Live/Registered	Joan Fleischman MD PC 2011-09-06
SOFTOUCH 85213089 not registered Dead/Abandoned	Softouch Concepts, Inc. 2011-01-07