ReliaTack

GUDID 20884521726380

Articulating Reloadable Fixation Device

Covidien LP

Endoscopic manual linear stapler

• Primary Device ID: 20884521726380
• NIH Device Record Key: 8c4b21f5-75c0-4824-b386-103a48cf14e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReliaTack
• Version Model Number: RELTACK4xDPTSW
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521726383 [Primary]
GS1	20884521726380 [Package]; Contains: 10884521726383; Package: CASE [6 Units]; In Commercial Distribution
GS1	30884521726387 [Package]; Package: PACK_OR_INNER_PACK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151659

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: 4
• Public Version Date: 2023-07-25
• Device Publish Date: 2018-04-07

On-Brand Devices [ReliaTack]

• 10884521202412: Reload with Standard Purchase Tacks;5 Violet Absorbable Tacks
• 10884521202405: Violet Deep Purchase Absorbable Tacks
• 10884521202382: Reload with Standard Purchase Tacks;10 Violet Absorbable Tacks
• 10884521202375: Violet Deep Purchase Absorbable Tacks
• 20884521726366: Articulating Reloadable Fixation Device
• 20884521726359: Articulating Reloadable Fixation Device
• 20884521726342: Violet Standard Purchase Absorable Tacks
• 20884521726335: Violet Standard Purchase Absorable Tacks
• 20884521726380: Articulating Reloadable Fixation Device
• 40884521202420: Articulating Reloadable Fixation Device, Violet Strand Purchase Absorbable Tacks, (3) 8 Tack Rel
• 30884521726370: Articulating Reloadable Fixation Device
• 40884521202390: Articulating Reloadable Fixation Device, Violet Strand Purchase Absorbable Tacks