AccessGUDID - DEVICE: Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet (00801741030383)

GUDID

Device Identifier (DI) Information

Brand Name: Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet
Version or Model: 190500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190500
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741030383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bardex® Heyman Nephrostomy Short Tip Councill Model Hollow Stylet for use with Bard® Nephrostomy Short Tip Councill Catheters

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?
47443	Suprapubic needle, single-use	A hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with a bladder prolapse. The needle is typically made of a high-grade stainless steel rod (curved or malleable) with a pointed tip and an eye or notch at the distal end to help position the sling. This device can be made of metal and/or synthetic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOD	CATHETER, UROLOGICAL

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: 920515d3-2f60-4b12-8fc6-6264606de51d
Public Version Date: November 19, 2020
Public Version Number: 3
DI Record Publish Date: July 28, 2016