Mighty Wire™ MW352604J

GUDID 10884450563981

Merit Medical Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use

Primary Device ID	10884450563981
NIH Device Record Key	f977de4c-3729-49a7-9f3d-de1ae5c843cb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mighty Wire™
Version Model Number	Initial Release
Catalog Number	MW352604J
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	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450563984 [Primary]
GS1	10884450563981 [Package] Contains: 00884450563984 Package: [5 Units] In Commercial Distribution
GS1	20884450563988 [Package] Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230418

FDA Product Code

DQX	Wire, guide, catheter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-03
Device Publish Date	2024-03-26

On-Brand Devices [Mighty Wire™]

10884450564087	Initial Release
20884450564053	Initial Release
20884450564060	Initial Release
10884450564001	Initial Release
20884450563933	Initial Release
10884450563981	Initial Release
20884450563964	Initial Release
10884450563998	Initial Release
10884450563950	Initial Release
00884450564042	Initial Release
10884450564148	Initial Release
20884450564015	Initial Release
10884450564070	Initial Release
20884450564039	Initial Release
10884450563943	Initial Release
20884450564138	Initial Release

Trademark Results [Mighty Wire]

Mark Image Registration \| Serial	Company Trademark Application Date
MIGHTY WIRE 90081058 not registered Live/Pending	Merit Medical Systems, Inc. 2020-07-29