AccessGUDID - DEVICE: Stylet (00607915111427)

GUDID

Device Identifier (DI) Information

Brand Name: Stylet
Version or Model: A4S980
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: APPLIED MEDICAL RESOURCES CORPORATION

Primary DI Number: 00607915111427
Issuing Agency: GS1
Commercial Distribution End Date: April 25, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 187129135 *Terms of Use

Device Description: Catheter Stylet

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:	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?
62919	Vascular catheter stylet	A thin sterile wire intended to be inserted within the lumen of a vascular catheter [e.g., peripheraly inserted venous catheter (PICC)] to stiffen and/or maintain the shape of the catheter to facilitate insertion; it is not intended for introduction into the coronary vasculature. It may be magnetic to enable use with a magnetic tracking system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy

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
Length: 80 Centimeter
Device Size Text, specify: 0.009 Inch Dia

Device Record Status

Public Device Record Key: f57082a5-e076-4c33-807c-5f76dc26b7da
Public Version Date: February 08, 2019
Public Version Number: 3
DI Record Publish Date: August 19, 2016