AccessGUDID - DEVICE: Jawz Endomyocardial Biopsy Forceps (00886333206834)

GUDID

Device Identifier (DI) Information

Brand Name: Jawz Endomyocardial Biopsy Forceps
Version or Model: 190085
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190085
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333206834
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Jawz Endomyocardial Biopsy Forceps 7F x 105cm Straight

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWZ	Device, Biopsy, Endomyocardial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951447	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7F x 105cm

Device Record Status

Public Device Record Key: ba6a59ee-5bba-426a-b1dc-5916fe298155
Public Version Date: September 10, 2019
Public Version Number: 4
DI Record Publish Date: September 16, 2016