AccessGUDID - DEVICE: BARD® PARSONNET (00801741090004)

GUDID

Device Identifier (DI) Information

Brand Name: BARD® PARSONNET
Version or Model: 007606
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 007606
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 00801741090004
Issuing Agency: GS1
Commercial Distribution End Date: September 29, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: BARD® PARSONNET™ Vascular Probe 2.5 mm x 45 cm

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?
38128	Vascular dilator, single-use	A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWP	DILATOR, VESSEL, SURGICAL

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
Length: 45 Centimeter
Device Size Text, specify: Tip Size, 2.5 Millimeters

Device Record Status

Public Device Record Key: 7c4dbad0-5f22-49f4-9594-56e4c721704e
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: September 19, 2016