MTG EZ-Gripper®

Basic Information

• Brand Name: MTG EZ-Gripper®
• Primary DI: 00892673002661
• Version / Model: 52112
• Company Name: MEDICAL TECHNOLOGIES OF GEORGIA, INC.
• Labeler DUNS: 011005491
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 87df6f78-c196-4d36-8554-8f637162dde2

Device Description

Pre-Lubricated Closed System Intermittent Catheter - Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
45605	Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10892673002668	GS1		50	In Commercial Distribution
Primary	00892673002661	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080878	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry , Keep away from direct sunlight