AccessGUDID - DEVICE: Introducer Needle (00801741045134)

GUDID

Device Identifier (DI) Information

Brand Name: Introducer Needle
Version or Model: 5584180
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5584180
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741045134
Issuing Agency: GS1
Commercial Distribution End Date: June 27, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: Introducer Needle 18 ga

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?
61502	Vascular catheter introduction needle	A sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). 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 [?]
K082580	000

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
Needle Gauge: 18 Gauge
Length: 70 Millimeter

Device Record Status

Public Device Record Key: 3837ba06-1c22-42cc-b3d8-f3af4943cb09
Public Version Date: December 19, 2024
Public Version Number: 6
DI Record Publish Date: February 22, 2016