AccessGUDID - DEVICE: CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSCARDIOVASCULAR AND VASCULAR G (00884908028034)

GUDID

Device Identifier (DI) Information

Brand Name: CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSCARDIOVASCULAR AND VASCULAR G
Version or Model: MC150J
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MC150J
Company Name: Medical Components, Inc.

Primary DI Number: 00884908028034
Issuing Agency: GS1
Commercial Distribution End Date: January 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 0.035" (0.90MM) X 150CM0.035" (0 J/FLEX GUIDEWIREJ/FLEX GUIDEWIRE

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":	Yes
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?
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQX	Wire, guide, catheter

FDA Premarket Submission

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

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
No Device Sizes

Device Record Status

Public Device Record Key: 355a05cd-763b-4050-908b-7a4dfd2c43e2
Public Version Date: February 05, 2021
Public Version Number: 2
DI Record Publish Date: October 24, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50884908028039	4	30884908028035	2021-01-29	Not in Commercial Distribution	box
30884908028035	10	00884908028034	2021-01-29	Not in Commercial Distribution	inner box