FDA.reportPublic FDA data

Novatome™

Primary DI
00884450392829
Brand
Novatome™
Company
Merit Medical Systems, Inc.
Model
C
Catalog number
SU103-50
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWZDEVICE, BIOPSY, ENDOMYOCARDIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWZDevice, Biopsy, EndomyocardialCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450392826PackageGS160In Commercial Distribution
00884450392829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445039282610884450392826
00884450392829008844503928298844503928290884450392829

GMDN Terms#

Term, Definition table
TermDefinition
Endomyocardial biopsy forceps, single-useA sterile grasping instrument designed to obtain tissue samples from the inner walls of the heart (endomyocardium) typically for histopathological examination. It is typically a flexible metal coil or plastic tube with a pair of scissors-like cups with cutting edges around their rims at the distal end which are operated by a handle attached at the proximal end. It is usually introduced percutaneously through the jugular vein or femoral artery (during catheterization). Acquired tissue samples are typically used for assessment of early rejection of a transplanted heart, cardiomyopathy and myocarditis diagnosis, or detection of antracycline cardiotoxicity. This is a single-use device.

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

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
00884450392843Novatome™Merit Medical Systems, Inc.DWZ2026-02-18
10884450392826Novatome™Merit Medical Systems, Inc.DWZ2026-02-18
10884450392840Novatome™Merit Medical Systems, Inc.DWZ2026-02-18
00884450392799Novatome™Merit Medical Systems, Inc.DWZ2026-02-14
10884450392796Novatome™Merit Medical Systems, Inc.DWZ2026-02-14
10705032056120BIOPSY FORCEPS STDCordis US Corp.DWZ2024-02-23
20705032056127BIOPSY FORCEPS STDCORDIS CORPORATIONDWZ2024-02-23
10705032056090Biopsy Forceps Cordis US Corp.DWZ2021-01-26
10705032056106Biopsy Forceps Cordis US Corp.DWZ2021-01-26
10705032056113Biopsy Forceps CORDIS CORPORATIONDWZ2021-01-26
20705032056097Biopsy Forceps CORDIS CORPORATIONDWZ2021-01-26
20705032056103Biopsy Forceps CORDIS CORPORATIONDWZ2021-01-26
20705032056110Biopsy Forceps CORDIS CORPORATIONDWZ2021-01-26
00889858616225CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858616232CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858618885CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619653CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619660CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619677CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619684CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619691CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619707CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619714CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
00889858619721CardioGRAFT-MC™LIFENET HEALTHDWZ2020-07-27
04058749000016NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000023NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000030NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000047NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000054NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000061NAFehling Instruments GmbH & Co. KGDWZ2017-06-23