FDA.reportPublic FDA data

ultraCbx

Primary DI
00816349011313
Brand
ultraCbx
Company
Lake Region Medical
Model
LR1BR001
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00816349011313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816349011313008163490113138163490113130816349011313

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
Length50Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
031108704
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10816349013536GuideRight404569-1404569-12026-03-24
10816349013543GuideRight404570-1404570-12026-03-24
10816349013550GuideRight404578-1404578-12026-03-24
10816349013567GuideRight404571-1404571-12026-03-24
10816349013574GuideRight404577-1404577-12026-03-24
10816349013581GuideRight404610-1404610-12026-03-24
10816349013598GuideRight404617-1404617-12026-03-24
10816349013604GuideRight404840-1404840-12026-03-24
10816349013611GuideRight404843-1404843-12026-03-24
10816349013628GuideRight404844-1404844-12026-03-24
10816349013635GuideRight404878-1404878-12026-03-24
10816349013642GuideRight404568-1404568-12026-03-24
10816349013659GuideRight404555-1404555-12026-03-24
10816349013666GuideRight404560-1404560-12026-03-24
10816349015097IntuitionIN32180JABFBF-007V2026-01-06
10816349014861PV-Tracker™990045ABFBF-003V2025-02-12
08714729761761ZIPwire™M006630205B0M006630205B02016-10-31
08714729761778ZIPwire™M006630206B0M006630206B02016-10-31
08714729761785ZIPwire™M006630209B0M006630209B02016-10-31
08714729761792ZIPwire™M006630223B0M006630223B02016-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450392826Novatome™Merit Medical Systems, Inc.DWZ2026-02-18
10884450392840Novatome™Merit Medical Systems, Inc.DWZ2026-02-18
10884450392796Novatome™Merit Medical Systems, Inc.DWZ2026-02-14
20705032056127BIOPSY FORCEPS STDCORDIS CORPORATIONDWZ2024-02-23
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
04058749000078NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000085NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000092NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
04058749000108NAFehling Instruments GmbH & Co. KGDWZ2017-06-23
00816349011320ultraCbxLake Region MedicalDWZ2016-09-24
00817428020196SparrowHawkATC TECHNOLOGIES, INC.DWZ2016-09-24