easyEndoTM Lite Loading Unit for Single Use N60B

GUDID 66925776102511

Lite Loading Unit, 60mm long, staple height 3.5mm, blue

Ezisurg Medical Co., Ltd.

Endoscopic manual linear cutting stapler, single-use

• Primary Device ID: 66925776102511
• NIH Device Record Key: 65794acf-1c84-4b28-a749-163088f4e0c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easyEndoTM Lite Loading Unit for Single Use
• Version Model Number: N60B
• Catalog Number: N60B
• Company DUNS: 421348845
• Company Name: Ezisurg Medical Co., Ltd.
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	06925776102519 [Primary]
GS1	66925776102511 [Package]; Contains: 06925776102519; Package: paper box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210909

FDA Product Code

• GDW: Staple, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-18
• Device Publish Date: 2021-08-10

On-Brand Devices [easyEndoTM Lite Loading Unit for Single Use]

• 66925776102535: Lite Loading Unit, 60mm long, staple height 4.1mm, green
• 66925776102467: Lite Loading Unit, 45mm long, staple height 3.5mm, blue
• 66925776102450: Lite Loading Unit, 45mm long, staple height 2.5mm, white
• 06925776102441: Lite Loading Unit, 45mm long, staple height 2.0mm, grey
• 66925776102528: Lite Loading Unit, 60mm long, staple height 3.8mm, gold
• 66925776102511: Lite Loading Unit, 60mm long, staple height 3.5mm, blue
• 66925776102504: Lite Loading Unit, 60mm long, staple height 2.5mm, white
• 66925776102498: Lite Loading Unit, 60mm long, staple height 2.0mm, grey
• 66925776102481: Lite Loading Unit, 45mm long, staple height 4.1mm, green
• 66925776102474: Lite Loading Unit, 45mm long, staple height 3.8mm, gold