Jawz Endomyocardial Biopsy Forceps

Basic Information

• Brand Name: Jawz Endomyocardial Biopsy Forceps
• Primary DI: 00886333206797
• Version / Model: 190070
• Catalog Number: 190070
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2019-09-10
• Public Version Status: Update
• Public Device Record Key: 2eeb2e24-ac41-49a2-930d-61e0c798a0d2

Device Description

Jaw Endomyocardial Biopsy Forceps 6F x 105cm Straight

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	870.4075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46679	Endomyocardial biopsy forceps, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333206791	GS1	Box	10	In Commercial Distribution
Primary	00886333206797	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K951447	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6F x 105cm