MT

Basic Information

• Brand Name: MT
• Primary DI: 06932503535557
• Version / Model: STA00005
• 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: 3a4843d3-55b6-4f1b-a1da-a45687b1c20a

Device Description

Uncoated,20 copies per box

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: MR Conditional
• 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
PLK	Tympanic Membrane Direct Contact Hearing Aid	Ear, Nose, Throat	874.3315	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61208	Gastrointestinal endoscopic clip, long-term, non-bioabsorbable	A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06932503535557	GS1
Package	16932503535554	GS1	BOX	1	In Commercial Distribution
Package	26932503535551	GS1	CASE	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K212748	000