AccessGUDID - DEVICE: Percutaneous Micro-Introducer Kit (00886333215003)

GUDID

Device Identifier (DI) Information

Brand Name: Percutaneous Micro-Introducer Kit
Version or Model: 497802
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 497802
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333215003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: 5F Percutaneous Micro-Introducer Kit

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:	Yes
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?
46488	Magnetocardiography system	An assembly of devices used to non-invasively detect, measure, and display bio-magnetic signals produced by electrically-active neural tissue of the heart that provide diagnostic information about cardiac electrophysiology (EP) [magnetocardiography (MCG)]. It typically consists of a fixed or moveable gantry, a patient table, a dewar [vessel containing liquid helium (He)], dedicated software, and a superconducting quantum interference device (SQUID) sensor array that measures the magnetic fields created by electrical current flowing with neurons. It may be sited within a magnetically-shielded room (MSR), and is used for cardiac mapping and the diagnosis of heart disorders.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFL	Percutaneous Sheath Introducer Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 5F

Device Record Status

Public Device Record Key: 1f16d1b7-da56-4847-a8b8-3bd8c9e0d2ef
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2016