FDA.reportPublic FDA data

Micro ACE™

Primary DI
10884450783341
Brand
Micro ACE™
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
ACE500SSS
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232609000Micro Ace™ Advanced Micro Access SystemMerit Medical Systems, Inc.2023-09-27DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450783341PackageGS110In Commercial Distribution
00884450783344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445078334110884450783341
00884450783344008844507833448844507833440884450783344

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24
00884450277652Safety Paracentesis Procedure TrayInitial ReleaseSPPT-8F-10S2026-09-22
00884450416723SureCrossDSC18652026-09-22
00884450422755SureCrossDSC14902026-09-22
00884450423110SureCrossDSC14652026-09-22
00884450427170SureCrossDSC141352026-09-22
00884450428016Merit Medical®Initial ReleaseK10-03360H2026-09-22
00884450435526Merit Medical®Initial ReleaseK09-11159A2026-09-22
00884450445419Merit Medical®Initial ReleaseK09-01589X2026-09-22
00884450473313Merit Medical®Initial ReleaseK09-14357A2026-09-22
00884450852279Merit Medical®Initial ReleasePC8112026-09-22
00884450852286Merit Medical®Initial ReleasePC8122026-09-22
10884450489809Prelude SNAP™APLSX-25112026-09-22
10884450489816Prelude SNAP™APLSS-10062026-09-22
10884450489823Prelude SNAP™APLSS-10072026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
00685447020264VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020271VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020288VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020295VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
04251244502768Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
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04251244501983Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
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04251244502003Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
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04251244502065Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDRE2023-09-01