MT

Basic Information

• Brand Name: MT
• Primary DI: 06932503562522
• Version / Model: SML10
• 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: 3
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 1e9480ba-4391-4406-8ec6-a9ebcdae4ca4

Device Description

Product is sky-blue viscous liquid, the content is 10ml. Initial packaging is the syringe.

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
PLL	Submucosal Injection Agent	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60785	Injectable charcoal tattoo marker	An implantable suspension of charcoal intended to be injected subcutaneously (e.g., under ultrasound imaging) to mark the skin over the site of a lump/lesion, or into deeper tissues to provide a visual mark for subsequent surgical excision. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16932503562529	GS1	BOX	12	In Commercial Distribution
Primary	06932503562522	GS1
Package	26932503562526	GS1	CASE	9	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K200071	000