MT

Basic Information

• Brand Name: MT
• Primary DI: 06932503534673
• Version / Model: EUS-22-1-F
• Company Name: Micro-Tech (Nanjing) Co., Ltd.
• Labeler DUNS: 530269083
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-28
• Public Version: 1
• Public Version Date: 2023-07-06
• Public Version Status: New
• Public Device Record Key: 0e8efaca-154a-420d-bc2e-f117b5f1a81c

Device Description

Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2
FCG	Biopsy Needle	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16932503534670	GS1	BOX	1	In Commercial Distribution
Primary	06932503534673	GS1
Package	26932503534677	GS1	CASE	5	In Commercial Distribution
Package	36932503534674	GS1	Transport box	2	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K212852	000