FDA.reportPublic FDA data

Merit Maestro®

Primary DI
10884450315962
Brand
Merit Maestro®
Company
Merit Medical Systems, Inc.
Model
00884450315965
Catalog number
28MC24130SN-I
Published
2019-05-29
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
10884450315962PackageGS110In Commercial Distribution
00884450315965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445031596210884450315962
00884450315965008844503159658844503159650884450315965

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
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106247334CARDINAL HEALTHCardinal Health 200, LLCOJV2023-08-18
10195594797751CARDINAL HEALTHCardinal Health 200, LLCOJV2023-08-02
10197106059609CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-19
10197106162712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-05
10197106244470CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-16
10197106245224CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-15
10197106163962CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-14
10197106229132CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-05
10197106221785CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106236727CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106170540CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-18
10197106277829CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-18
10197106188712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-11
10197106262597CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-03
10197106110263CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-02
10197106243039CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-01
10197106244432CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-28
10197106258484CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-28
10197106246665CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-27
10197106220146CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-21
10197106226667CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-20
10197106229484CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106234334CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106240816CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106154281CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106182659CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106056516CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106136508CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106196533CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106175644CARDINAL HEALTHCardinal Health 200, LLCOJV2023-03-29