ReliaTack

GUDID 20884521726380

Articulating Reloadable Fixation Device

Covidien LP

Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler Endoscopic manual linear stapler 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