ILAN 3972

GUDID 20884521063171

Knifeless Loading Unit

Covidien LP

Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting

• Primary Device ID: 20884521063171
• NIH Device Record Key: b8d0be23-f6b3-49fe-9271-a8be2be2f110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILAN
• Version Model Number: 3972
• Catalog Number: 3972
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter
• Length: 100 Millimeter
• Height: 3.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521063174 [Primary]
GS1	20884521063171 [Package]; Contains: 10884521063174; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K885222

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

Devices Manufactured by Covidien LP

• 10884521744134 - TruClear: 2024-04-23 Calibration Insert
• 10884521744141 - TruClear: 2024-04-23 Calibration Insert
• 10884521557048 - INVOS: 2024-04-22 Docking Station
• 10884521833869 - Endoflip: 2024-04-22 Refurbished 300 Pump System With Pre-Use Tube
• 20884521140216 - ClosureFast: 2024-04-15 Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m)
• 10884521543430 - LiquiBand Exceed: 2024-04-15 2-Octyl Cyanoacrylate
• 20884521140209 - ClosureFast: 2024-04-10 Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
• 10884521539921 - VenaSeal: 2024-04-09 VenaSeal Closure System