AccessGUDID - DEVICE: Introducer Needle (10801741087773)

GUDID

Device Identifier (DI) Information

Brand Name: Introducer Needle
Version or Model: S03118-350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S03118-350
Company Name: Bard Access Systems, Inc.

Primary DI Number: 10801741087773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: SecLoc,INTRO 18Gx3.5 ST

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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 18 Gauge
Length: 3.5 Inch

Device Record Status

Public Device Record Key: 2415f050-e17d-45c3-acf5-e7fdad7615ca
Public Version Date: June 06, 2024
Public Version Number: 3
DI Record Publish Date: February 22, 2016