AccessGUDID - DEVICE: Posi-Stick Introducer Set (H862PS238SW0)

GUDID

Device Identifier (DI) Information

Brand Name: Posi-Stick Introducer Set
Version or Model: PS2-38SW
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PS2-38SW
Company Name: URESIL, LLC

Primary DI Number: H862PS238SW0
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 Intro. Set w/PT Marker & .038" Super-Stiff GW

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?
46448	Fascial tissue dilator, single-use	A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, 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: 0.038 Inch

Device Record Status

Public Device Record Key: e323a802-4055-48cd-bcdd-2be354acb67f
Public Version Date: September 12, 2019
Public Version Number: 3
DI Record Publish Date: August 31, 2016