AccessGUDID - DEVICE: MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREMODIFICATION TO VASCUPUNCTURE PICC G (00884908032321)

GUDID

Device Identifier (DI) Information

Brand Name: MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREMODIFICATION TO VASCUPUNCTURE PICC G
Version or Model: MRI19181301
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MRI19181301
Company Name: Medical Components, Inc.

Primary DI Number: 00884908032321
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: 0.018" (0.47MM) X 130CM MARKED NITINOL WIRE WITH RADIOPAQUE TIP WITH HYDROPHILIC COATING

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?
58115	Peripheral vascular guidewire, manual	A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It 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: 13c0352e-e632-4a2d-9628-78edaa06dd43
Public Version Date: December 22, 2021
Public Version Number: 4
DI Record Publish Date: July 10, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30884908032322	10	00884908032321	2021-01-29	Not in Commercial Distribution	inner box
50884908032326	4	30884908032322	2021-01-29	Not in Commercial Distribution	box