AccessGUDID - DEVICE: Disposable guide for 3D endocavity end-fire (03665134000011)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable guide for 3D endocavity end-fire
Version or Model: KDNG00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KOELIS

Primary DI Number: 03665134000011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 290318455 *Terms of Use

Device Description: The product concerned is a plastic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. The guide is composed of 2 parts welded together to have: • a channel to receive and guide the linear instrument • a clip to allow the guide stability on the transducer • 2 pins for attachment in the notches of the probe • a guide cone to introduce easily the needle into the tube

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?
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180970	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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 79218aab-3004-4a3c-8afe-026186bd515b
Public Version Date: April 30, 2025
Public Version Number: 11
DI Record Publish Date: July 20, 2018