FDA.reportPublic FDA data

Procure™

Primary DI
05415067009555
Brand
Procure™
Company
ST. JUDE MEDICAL, INC.
Model
408297
Catalog number
408297
Device description
Endomyocardial Biopsy Forceps
Published
2016-04-20
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

Contact Domains#

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
K991486000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991486000ULTRA-CBXMedcanica, Inc.1999-11-05DWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067009555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067009555054150670095555415067009555

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Length50Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Do not use if package is damaged.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22
05415067016683NA231623162015-09-08

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
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