Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)

GUDID 16932503534861

Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1245~1285mm,FNA needle

Micro-Tech (Nanjing) Co., Ltd.

Ultrasound aspiration biopsy procedure kit
Primary Device ID16932503534861
NIH Device Record Key17cd216b-7bef-4a36-9d52-e9726a53c652
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)
Version Model NumberEUS-19-0-FS2
Company DUNS530269083
Company NameMicro-Tech (Nanjing) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com
Phone877-552-4027
Emailinfo@micro-tech-usa.com

Device Dimensions

Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS106932503534864 [Primary]
GS116932503534861 [Package]
Contains: 06932503534864
Package: BOX [1 Units]
In Commercial Distribution
GS126932503534868 [Package]
Package: CASE [5 Units]
In Commercial Distribution
GS136932503534865 [Package]
Contains: 26932503534868
Package: Transport Case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-08
Device Publish Date2025-04-30

On-Brand Devices [Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)]

16932503534885Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure:
16932503534861Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure:
16932503534724Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure:
16932503534700Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure:

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