Cure Ultra Male Catheter

GUDID 20815947021032

Sterile Intermittent Catheter, Straight Tip

CURE MEDICAL LLC

Single-administration urethral drainage catheter

• Primary Device ID: 20815947021032
• NIH Device Record Key: 27fd2c95-27ef-4be1-b25c-7517ceb9fe22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cure Ultra Male Catheter
• Version Model Number: ULTRA M8
• Company DUNS: 070643426
• Company Name: CURE MEDICAL LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Length: 16 Inch
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter
• Catheter Gauge: 8 French
• Length: 41 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815947021038 [Primary]
GS1	10815947021035 [Package]; Contains: 00815947021038; Package: Box [30 Units]; In Commercial Distribution
GS1	20815947021032 [Package]; Contains: 10815947021035; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080881

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-07

On-Brand Devices [Cure Ultra Male Catheter]

• 20815947021087: Sterile Intermittent Catheter, Straight Tip
• 20815947021070: Sterile Intermittent Catheter, Straight Tip
• 20815947021063: Sterile Intermittent Catheter, Straight Tip
• 20815947021056: Sterile Intermittent Catheter, Straight Tip
• 20815947021049: Sterile Intermittent Catheter, Straight Tip
• 20815947021032: Sterile Intermittent Catheter, Straight Tip