MTG EZ-Advancer® Soft

GUDID 10851593006033

Pre-Lubricated Closed System Intermittent Catheter - Kit

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 10851593006033
• NIH Device Record Key: 2376fcde-405d-4432-a36b-8a2ae3b8f2cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTG EZ-Advancer® Soft
• Version Model Number: 31212
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry , Keep away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851593006036 [Primary]
GS1	10851593006033 [Package]; Contains: 00851593006036; Package: [100 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: 2016-09-13

On-Brand Devices [MTG EZ-Advancer® Soft]

• 10851593006040: Pre-Lubricated Closed System Intermittent Catheter - Kit
• 10851593006033: Pre-Lubricated Closed System Intermittent Catheter - Kit