Surgitie EL-22-LN

GUDID 10884521099623

Ligating Loop

Covidien LP

Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop Endoscopic ligature loop

• Primary Device ID: 10884521099623
• NIH Device Record Key: 2b805e4e-2726-4ecd-9f7a-ee4c4fed20fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgitie
• Version Model Number: EL-22-LN
• Catalog Number: EL-22-LN
• 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: 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(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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521099623 [Package]; Contains: 20884521099620; Package: CASE [6 Units]; In Commercial Distribution
GS1	20884521099620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904588

FDA Product Code

• GAL: SUTURE, ABSORBABLE, NATURAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [Surgitie]

• 10884521099623: Ligating Loop
• 20884521099668: Ligating Loop with Delivery System
• 20884521099651: Ligating Loop with Delivery System
• 20884521099644: Ligating Loop with Delivery System
• 20884521099637: Ligating Loop with Delivery System
• 20884521099545: Ligating Loop
• 20884521099538: Ligating Loop with Delivery System
• 20884521099521: Ligating Loop with Delivery System
• 20884521099460: Ligating Loop with Delivery System