AccessGUDID - DEVICE: Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) (06932503534581)

GUDID

Device Identifier (DI) Information

Brand Name: Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)
Version or Model: EUS-19-0-N
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503534581
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Sheath: 1.8mm, Needle: 1.1mm, Needle Length out of sheath: 80mm, Material: Co-Cr Alloy, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle

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":	Yes
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?
10403	Ultrasound aspiration biopsy procedure kit	A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172309	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: 19 Gauge

Device Record Status

Public Device Record Key: d59b6a15-b866-4a5d-a40e-6d4b09c4d8ee
Public Version Date: October 14, 2024
Public Version Number: 3
DI Record Publish Date: April 03, 2023