Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)

GUDID 16932503534878

Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1245~1285mm,FNB needle

Micro-Tech (Nanjing) Co., Ltd.

Ultrasound aspiration biopsy procedure kit
Primary Device ID16932503534878
NIH Device Record Keyf92dd936-e184-4882-a5df-2534c4782956
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)
Version Model NumberEUS-22-1-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 Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS106932503534871 [Primary]
GS116932503534878 [Package]
Contains: 06932503534871
Package: BOX [1 Units]
In Commercial Distribution
GS126932503534875 [Package]
Package: CASE [5 Units]
In Commercial Distribution
GS136932503534872 [Package]
Contains: 26932503534875
Package: Transport Case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy Needle

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 [Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)]

16932503534878Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure:
16932503534854Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure:
16932503534717Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure:
16932503534694Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure:

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.