Surgineedle

GUDID 10884521080812

Insufflation Needle

Covidien LP

Spring-loaded pneumoperitoneum needle, single-use

• Primary Device ID: 10884521080812
• NIH Device Record Key: 7b1289f9-0524-4998-a8f7-695a382502a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgineedle
• Version Model Number: 172016
• 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
• 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
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Device Size Text, specify: 0
• Length: 150 Millimeter

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
• 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
• 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
• 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
• 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	10884521080812 [Package]; Contains: 20884521080819; Package: Case [12 Units]; In Commercial Distribution
GS1	20884521080819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863330

FDA Product Code

• FHO: Pneumoperitoneum Needle

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: 2016-10-20

On-Brand Devices [Surgineedle]

• 10884521080812: Insufflation Needle
• 20884521080802: Insufflation Needle