easyEndoTM Lite Linear Cutting Stapler for Single Use U12M45

GUDID 16925776102585

Lite Linear Cutting Stapler, 350mm long, 12.3mm diameter

Ezisurg Medical Co., Ltd.

Endoscopic manual linear cutting stapler, single-use

• Primary Device ID: 16925776102585
• NIH Device Record Key: 09ae8b64-bcd7-4f81-883c-1cb302dafb0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easyEndoTM Lite Linear Cutting Stapler for Single Use
• Version Model Number: U12M45
• Catalog Number: U12M45
• Company DUNS: 421348845
• Company Name: Ezisurg Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06925776102588 [Primary]
GS1	16925776102585 [Package]; Contains: 06925776102588; Package: paper box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210909

FDA Product Code

• GAG: Stapler, Surgical

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 Linear Cutting Stapler for Single Use]

• 16925776102578: Lite Linear Cutting Stapler, 260mm long, 12.3mm diameter
• 06925776102540: Lite Linear Cutting Stapler, 440mm long, 12.3mm diameter
• 16925776102615: Lite Linear Cutting Stapler, 350mm long, 12.3mm diameter
• 16925776102608: Lite Linear Cutting Stapler, 260mm long, 12.3mm diameter
• 16925776102592: Lite Linear Cutting Stapler, 440mm long, 12.3mm diameter
• 16925776102585: Lite Linear Cutting Stapler, 350mm long, 12.3mm diameter