AccessGUDID - DEVICE: Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) (06932503534635)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 06932503534635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm.

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
FCG	Biopsy Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212852	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: 79fd77c7-6bf5-4c31-b428-ebae3dd55129
Public Version Date: October 14, 2024
Public Version Number: 3
DI Record Publish Date: June 28, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
16932503534632	1	06932503534635	In Commercial Distribution	BOX
26932503534639	5	16932503534632	In Commercial Distribution	CASE
36932503534636	2	26932503534639	In Commercial Distribution	Transport box