MTG EZ-Gripper® Long

GUDID 10851593006408

Pre-Lubricated Closed System Intermittent Catheter-Kit

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 10851593006408
• NIH Device Record Key: 0bc70477-54ac-4841-8f58-f22ecdeb4557
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTG EZ-Gripper® Long
• Version Model Number: 52812
• Company DUNS: 011005491
• Company Name: MEDICAL TECHNOLOGIES OF GEORGIA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-788-0763
• Email: MTGcustomerservice@medtechga.com

Device Dimensions

• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851593006401 [Primary]
GS1	10851593006408 [Package]; Contains: 00851593006401; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080878

FDA Product Code

• KOD: Catheter, Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-10

On-Brand Devices [MTG EZ-Gripper® Long]

• 10851593006422: Pre-Lubricated Closed System Intermittent Catheter-Kit
• 10851593006415: Pre-Lubricated Closed System Intermittent Catheter-Kit
• 10851593006408: Pre-Lubricated Closed System Intermittent Catheter-Kit
• 10851593006392: Pre-Lubricated Closed System Intermittent Catheter 18in long
• 10851593006385: Pre-Lubricated Closed System Intermittent Catheter 18in Long
• 10851593006378: Pre-Lubricated Closed System Intermittent Catheter 18in long