MT

Basic Information

• Brand Name: MT
• Primary DI: 06932503525114
• Version / Model: DG-18-08-21
• 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: 2021-12-31
• Public Version: 1
• Public Version Date: 2022-01-10
• Public Version Status: New
• Public Device Record Key: 4678ebcb-9d84-4109-b5a1-5f25d59ffead

Device Description

The diameter of the spring tip is 1.8mm, the diameter of the wire guide rod is 0.8mm, and the effective working length is 2100mm.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16932503525111	GS1	box	10	In Commercial Distribution
Primary	06932503525114	GS1
Package	26932503525118	GS1	case	25	In Commercial Distribution