Ritus

GUDID 10884521811249

Peritoneal Dialysis Accessory Catheter Straightening Stylet

Covidien LP

Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet Peritoneal catheter stylet

• Primary Device ID: 10884521811249
• NIH Device Record Key: 7ea699d8-4cf1-4511-8bcd-bb7f72abaf74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ritus
• Version Model Number: 8888415646
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter
• Length: 44.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521811249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920515

FDA Product Code

• FJS: Catheter, peritoneal, long-term indwelling

Sterilization

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

[10884521811249]

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[10884521811249]

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[10884521811249]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [Ritus]

• 30884521803293: Preoperative Peritoneal Dialysis Catheter Stencil
• 10884521811249: Peritoneal Dialysis Accessory Catheter Straightening Stylet