FDA.reportPublic FDA data

Micro ACE™

Primary DI
10884450809621
Brand
Micro ACE™
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
ACE501PTE
Published
2024-04-13
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
10884450809621PackageGS110In Commercial Distribution
00884450809624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445080962110884450809621
00884450809624008844508096248844508096240884450809624

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. 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
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22
00884450421581Merit Medical®Initial ReleaseK12-08733A2026-07-21
00884450795705Merit Medical®Initial ReleaseK12-10248A2026-07-21
00884450457382C2 CryoBalloon™AFG-10132026-07-20
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04251244502768Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
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
04251244502058Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
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
04251244502102Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDRE2023-09-01