AccessGUDID - DEVICE: Bard® X-Force® Nephrostomy Balloon Dilation Catheter (00801741080722)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® X-Force® Nephrostomy Balloon Dilation Catheter
Version or Model: 995101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 995101
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741080722
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard® X-Force® Nephrostomy Balloon Dilation Catheter

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:	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?
10735	Nephrostomy catheter	A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJE	CATHETER, NEPHROSTOMY

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
Special Storage Condition, Specify: Do not store near radiation or ultraviolet light sources.

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Centimeter
Outer Diameter: 10 Millimeter

Device Record Status

Public Device Record Key: d51b3a4d-48b4-4f45-a24f-1a050c19bdc2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 16, 2016