Endo Stitch

GUDID 20884521100012

Suturing Device

Covidien LP

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• Primary Device ID: 20884521100012
• NIH Device Record Key: c879c6a1-b800-4c7d-ab7d-003527174b37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo Stitch
• Version Model Number: 173027
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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
• 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

• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 10 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521100015 [Primary]
GS1	20884521100012 [Package]; Contains: 10884521100015; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934738

FDA Product Code

• OCW: Endoscopic tissue approximation device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-25
• Device Publish Date: 2016-09-24

On-Brand Devices [Endo Stitch]

• 20884521100012: Suturing Device
• 20884521100005: Suturing Device