GIA Premium 030735L

GUDID 20884521031637

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

• Primary Device ID: 20884521031637
• NIH Device Record Key: 6d9a041d-f3a6-4eaa-9a77-44495b880252
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIA Premium
• Version Model Number: 030735L
• Catalog Number: 030735L
• 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

Device Dimensions

• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter
• Height: 3.8 Millimeter
• Length: 90 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• 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	10884521031630 [Primary]
GS1	20884521031637 [Package]; Contains: 10884521031630; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801590

FDA Product Code

• FHM: APPARATUS, SUTURING, STOMACH AND INTESTINAL

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: 2019-05-07
• Device Publish Date: 2018-08-10

On-Brand Devices [GIA Premium]

• 20884521031637: Loading Unit
• 10884521063402: Reusable Stapler
• 20884523007098: Loading Unit