AccessGUDID - DEVICE: Posi-Stick Introducer Set (H862PS2180)

GUDID

Device Identifier (DI) Information

Brand Name: Posi-Stick Introducer Set
Version or Model: PS2-18
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PS2-18
Company Name: URESIL, LLC

Primary DI Number: H862PS2180
Issuing Agency: HIBCC
Commercial Distribution End Date: September 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: Posi-Stick .018" (.046mm) 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:	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?
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
KGZ	Accessories, 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
Outer Diameter: 0.018 Inch

Device Record Status

Public Device Record Key: 001a68d0-bf5c-46bf-bc5a-0a5d98cdd303
Public Version Date: December 22, 2021
Public Version Number: 5
DI Record Publish Date: August 30, 2016