AccessGUDID - DEVICE: Coaxial Interventional Needle (04262410680425)

GUDID

Device Identifier (DI) Information

Brand Name: Coaxial Interventional Needle
Version or Model: KIM13/04T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ITP Innovative Tomography Products GmbH

Primary DI Number: 04262410680425
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341493551 *Terms of Use

Device Description: This needle is intended for puncture and injection.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAA	Needle, Aspiration And Injection, Disposable

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: 44 Millimeter
Needle Gauge: 13 Gauge

Device Record Status

Public Device Record Key: 5ea35c97-f25e-4cd0-8b6a-600c281a9bc4
Public Version Date: April 16, 2024
Public Version Number: 1
DI Record Publish Date: April 08, 2024