AccessGUDID - DEVICE: Introducer D3.5 mm, 167 mm, Trocar. (07290015487139)

GUDID

Device Identifier (DI) Information

Brand Name: Introducer D3.5 mm, 167 mm, Trocar.
Version or Model: FAC9200000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FAC9200000
Company Name: ICECURE MEDICAL LTD

Primary DI Number: 07290015487139
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514758619 *Terms of Use

Device Description: Consists of Mandrel (FAC9200000-1) and Cannula (FAC9200000-2)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
65809	Percutaneous non-endoscopic instrument access cannula	A hollow slender tubular instrument designed for percutaneous insertion to provide access for instruments (e.g., biopsy needle) under radiological image guidance [e.g., ultrasound] during procedures relating to tissue lesions (e.g., biopsy, ablation). The cannula includes a sharp trocar blade/mandrel to assist introduction and is intended for soft tissue access, however it might additionally be intended for non-impactive bone access. It is not a dedicated bone access cannula and is not an endoscopic (laparoscopic, arthroscopic) access cannula. Some types include a guide/stylet to help percutaneous insertion (e.g., during transperineal prostate biopsy). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDF	Guide, Needle, 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
Special Storage Condition, Specify: The packed introducers shall be stored in a dry, cool, well-ventilated and clean environment without corrosive gas.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 3.5 Millimeter
Shaft Length: 167 Millimeter

Device Record Status

Public Device Record Key: a0a81bbe-c93a-459b-a745-81f195f26e41
Public Version Date: March 06, 2025
Public Version Number: 9
DI Record Publish Date: October 24, 2019