FDA.reportPublic FDA data

Merit Maestro®

Primary DI
10884450357412
Brand
Merit Maestro®
Company
Merit Medical Systems, Inc.
Model
00884450357415
Catalog number
28MC21150ST-I
Published
2019-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450357412PackageGS110In Commercial Distribution
00884450357415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445035741210884450357412
00884450357415008844503574158844503574150884450357415

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956340435CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
10198956460164CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
50198956350289CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956413991CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956418101CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-23
50198956326437CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-19
50198956350920CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-16
50198956357059CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956363333CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956387872CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956334067CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956375756CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956344813CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-13
50198956020250CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956293791CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956314557CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-02
50198956258790CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
50198956316025CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
00884450306857Performa®Merit Medical Systems, Inc.OJV2026-01-29
50198956285895CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-23
50198956263008CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956300284CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956286915CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956300406CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956203011CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301212CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301823CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-13
50198956303452CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-07
50198956292831CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05
50198956305487CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05