GENTLECATH NELATON 501003

GUDID 00768455145461

NELATON CH12X16 IN

CONVATEC, PURCHASING DEPARTMENT

Single-administration urethral drainage catheter

• Primary Device ID: 00768455145461
• NIH Device Record Key: bf384c71-49b8-4864-9583-cd3ff64546ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENTLECATH NELATON
• Version Model Number: 501003
• Catalog Number: 501003
• 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: false
• 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: +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
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter
• Catheter Gauge: 12 French
• Length: 41 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455111411 [Package]; Package: Carton [100 Units]; In Commercial Distribution
GS1	00768455145461 [Primary]
GS1	10768455111418 [Package]; Contains: 00768455111411; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172924
• Premarket Notification: K896729

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: 2016-09-01

On-Brand Devices [GENTLECATH NELATON ]

• 00768455145492: NELATON CH18X16 IN
• 00768455145485: NELATON CH16X16 IN
• 00768455145478: NELATON CH14X16 IN
• 00768455145461: NELATON CH12X16 IN
• 00768455145454: NELATON CH10X16 IN
• 00768455145447: NELATON CH08X16 IN