MITEK SPORTS MEDICINE

Basic Information

• Brand Name: MITEK SPORTS MEDICINE
• Primary DI: 00815634020030
• Version / Model: 278014
• Company Name: Micromedics, Inc.
• Labeler DUNS: 066839630
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 2
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: ef5400d7-0ed3-4aab-bdfe-efac68747c52

Device Description

MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 10 CM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20815634020034	GS1	CASE	5	In Commercial Distribution
Package	10815634020037	GS1	INNER PACK	10	In Commercial Distribution
Primary	00815634020030	GS1