Micro ACE™ ACE521PTE

GUDID 10884450785123

Merit Medical Systems, Inc.

Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use

Primary Device ID	10884450785123
NIH Device Record Key	527b4aab-e0e5-4427-8782-6b6fc3f69bbb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Micro ACE™
Version Model Number	Initial Release
Catalog Number	ACE521PTE
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	00884450785126 [Primary]
GS1	10884450785123 [Package] Contains: 00884450785126 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K232609

FDA Product Code

DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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	2024-03-13
Device Publish Date	2024-03-05

On-Brand Devices [Micro ACE™]

10884450783365	00884450783368
10884450783334	00884450783337
10884450785116	00884450785119
10884450785123	Initial Release
10884450783341	Initial Release
10884450783358	Initial Release
10884450809652	A
10884450809621	A

Trademark Results [Micro ACE]

Mark Image Registration \| Serial	Company Trademark Application Date
MICRO ACE 98149605 not registered Live/Pending	Merit Medical Systems, Inc. 2023-08-24
MICRO ACE 75679506 2498780 Dead/Cancelled	HOLOVISION ACQUISITION COMPANY 1999-04-12
MICRO ACE 73568051 1398675 Dead/Cancelled	KUN NAN ENTERPRISE LTD 1985-11-12