TA Premium 015458L

GUDID 20884521047409

Loading Unit

Covidien LP

Surgical staple loading unit, non-cutting

• Primary Device ID: 20884521047409
• NIH Device Record Key: ea6d0490-c7cc-45d7-8b2c-aa81cb826955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TA Premium
• Version Model Number: 015458L
• Catalog Number: 015458L
• 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

Device Dimensions

• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 Millimeter
• Length: 55 Millimeter
• Height: 4.8 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521047402 [Primary]
GS1	20884521047409 [Package]; Contains: 10884521047402; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K855047

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2015-08-28

On-Brand Devices [TA Premium]

• 20884521047379: Vascular Loading Unit
• 20884521047430: Loading Unit
• 20884521047423: Loading Unit
• 20884521047409: Loading Unit
• 20884521047386: Loading Unit
• 20884521047362: Loading Unit
• 20884521047355: Loading Unit
• 10884521049000: Reusable Stapler
• 10884521048997: Reusable Stapler
• 10884521048980: Reusable Stapler