FDA.reportPublic FDA data

Biopsy Forceps

Primary DI
10705032056113
Brand
Biopsy Forceps
Company
CORDIS CORPORATION
Model
504302
Catalog number
504302
Device description
BIOPSY FORCEPS 5.5F STD 50CM
Published
2021-01-26
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810849000CORDIS BIOPSY FORCEPSCordis Corp.1981-04-17DWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032056110PackageGS11In Commercial Distribution
10705032056113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205611020705032056110
1070503205611310705032056113

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
806136177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000512AVANTI+402604T402604T2016-08-01
10705032000550AVANTI402605R402605R2016-08-01
10705032000772AVANTI+402611T402611T2016-08-01
10705032009751AVANTI504404X504404X2016-08-01
10705032009782AVANTI504407X504407X2016-08-01
10705032009805AVANTI504409X504409X2016-08-01
10705032009812AVANTI504504S504504S2016-08-01
10705032009829AVANTI504505S504505S2016-08-01
10705032009836AVANTI504505X504505X2016-08-01
10705032009843AVANTI504506S504506S2016-08-01
10705032009850AVANTI504506X504506X2016-08-01
10705032009867AVANTI504507X504507X2016-08-01
10705032009874AVANTI504508X504508X2016-08-01
10705032009928AVANTI504604T504604T2016-08-01
10705032009973AVANTI504605T504605T2016-08-01
10705032010009AVANTI504606D504606D2016-08-01
10705032010016AVANTI504606P504606P2016-08-01
10705032010023AVANTI504606S504606S2016-08-01
10705032010030AVANTI504606T504606T2016-08-01
10705032010054AVANTI504606X504606X2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450392829Novatome™Merit Medical Systems, Inc.DWZ2026-02-18
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
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