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
00884450430118Merit Medical®Initial ReleaseK12-05157A2026-08-27
00884450440544Merit ®ALR-STS0012026-08-27
00884450450970Merit Medical®ALR-CLP0022026-08-27
00884450466995Needle's Eye Snare®ALR-NES0022026-08-27
00884450685785SCOUT®TSSR05-012026-08-27
00884450685792SCOUT®TSSR10-012026-08-27
00884450685808SCOUT®TSSR75-012026-08-27
00884450685822SCOUT MD™BSGMD-012026-07-01
00884450685839SCOUT MD™BSGMD-022026-07-01
00884450840597Prelude Roadster™APG4F90S2026-08-27
10884450119836Prelude EASE™JPHR6F11025PW2026-08-27
00884450435748SCOUT®MSG-012026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450392850SCOUT MD™Initial ReleaseMDS05A-012026-05-28
00884450392867SCOUT MD™Initial ReleaseMDS05B-012026-05-28
00884450392874SCOUT MD™Initial ReleaseMDS05C-012026-05-28
00884450392881SCOUT MD™Initial ReleaseMDS05M-012026-05-28
00884450392935SCOUT MD™Initial ReleaseMDS75A-012026-05-28
00884450392942SCOUT MD™Initial ReleaseMDS75B-012026-05-28
00884450392959SCOUT MD™Initial ReleaseMDS75C-012026-05-28

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