Cure Ultra Male Catheter

GUDID 10815947021127

Sterile Intermittent Catheter, Coudé Tip

CONVATEC, PURCHASING DEPARTMENT

Single-administration urethral drainage catheter

• Primary Device ID: 10815947021127
• NIH Device Record Key: 71c3045e-cbdb-4bf0-9eac-d0ccdf0e4d8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cure Ultra Male Catheter
• Version Model Number: Ultra M16C
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• 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: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• 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: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 16 Inch
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter
• Catheter Gauge: 16 French
• Length: 41 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815947021120 [Primary]
GS1	10815947021127 [Package]; Contains: 00815947021120; Package: Box [10 Units]; In Commercial Distribution
GS1	20815947021124 [Package]; Package: Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072539

FDA Product Code

• EZD: Catheter, Straight

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-22
• Device Publish Date: 2022-02-14

On-Brand Devices [Cure Ultra Male Catheter]

• 10815947021134: Sterile Intermittent Catheter, Coudé Tip
• 10815947021127: Sterile Intermittent Catheter, Coudé Tip
• 10815947021110: Sterile Intermittent Catheter, Coudé Tip
• 10815947021103: Sterile Intermittent Catheter, Coudé Tip
• 10815947021097: Sterile Intermittent Catheter, Coudé Tip