FDA.reportPublic FDA data

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

Primary DI
16932503534878
Brand
Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
EUS-22-1-FS2
Device description
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
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212852000Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd.2021-12-06ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503534878PackageGS11In Commercial Distribution
26932503534875PackageGS15In Commercial Distribution
36932503534872PackageGS12In Commercial Distribution
06932503534871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250353487816932503534878
2693250353487526932503534875
3693250353487236932503534872
06932503534871069325035348716932503534871

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound aspiration biopsy procedure kitA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge22Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08
06932503516204Sphincterotome / short-wire compatibleRDSP-0530-231-12026-05-08
06932503575379Sphincterotome / short-wire compatibleRDSP-0220-1112026-05-08
06932503575386Sphincterotome / short-wire compatibleRDSP-0220-2112026-05-08
06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08
06932503575409Sphincterotome / short-wire compatibleRDSP-0220-2212026-05-08
06932503575416Sphincterotome / short-wire compatibleRDSP-0220-1312026-05-08
06932503575423Sphincterotome / short-wire compatibleRDSP-0220-2312026-05-08
06932503575430Sphincterotome / short-wire compatibleRDSP-0225-1112026-05-08
06932503575447Sphincterotome / short-wire compatibleRDSP-0225-2112026-05-08
06932503575454Sphincterotome / short-wire compatibleRDSP-0225-1212026-05-08

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