MTG Intermittent Catheter Coude-tip with hydrophilic low-friction coating.

GUDID 20851593006337

Intermittent Catheter Coude-tip with hydrophilic coating

MEDICAL TECHNOLOGIES OF GEORGIA, INC.

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 20851593006337
• NIH Device Record Key: 36979d9a-829b-43c4-b175-d554b28ce884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTG Intermittent Catheter Coude-tip with hydrophilic low-friction coating.
• Version Model Number: 81612
• 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: false
• 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

• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851593006333 [Primary]
GS1	10851593006330 [Package]; Contains: 00851593006333; Package: [30 Units]; In Commercial Distribution
GS1	20851593006337 [Package]; Contains: 10851593006330; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111405

FDA Product Code

• GBM: Catheter, Urethral

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

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