easyLCTM Linear Cutter Staplers and Loading Units for Single Use LCE100

GUDID 16925776119293

Linear Cutter Staplers, 100±2mm Length, green

Ezisurg Medical Co., Ltd.

Endoscopic manual linear cutting stapler, single-use

• Primary Device ID: 16925776119293
• NIH Device Record Key: 322a86f2-6dcd-46de-8b2e-292558056a94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easyLCTM Linear Cutter Staplers and Loading Units for Single Use
• Version Model Number: LCE100
• Catalog Number: LCE100
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06925776119296 [Primary]
GS1	16925776119293 [Package]; Contains: 06925776119296; Package: color box [1 Units]; In Commercial Distribution
GS1	76925776119295 [Package]; Package: traveling case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181657

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: 2025-01-15
• Device Publish Date: 2025-01-07

On-Brand Devices [easyLCTM Linear Cutter Staplers and Loading Units for Single Use]

• 16925776119439: Loading Unit, 100±2mm Long
• 16925776119422: Loading Unit, 80±2mm Long
• 16925776119415: Loading Unit, 60±2mm Long
• 16925776119408: Linear Cutter Staplers, 100±2mm Length, blue
• 16925776119392: Linear Cutter Staplers, 80±2mm Length, green
• 16925776119385: Linear Cutter Staplers, 60±2mm Length, green
• 16925776119378: Linear Cutter Staplers, 60±2mm Length, Blue
• 66925776119366: Loading Unit, 100±2mm Long, 4.8±0.2mm Height, green
• 66925776119359: Loading Unit, 100±2mm Long, 3.8±0.2mm Height, blue
• 66925776119342: Loading Unit, 80±2mm Long, 4.8±0.2mm Height, green
• 66925776119335: Loading Unit, 80±2mm Long, 3.8±0.2mm Height, blue
• 66925776119328: Loading Unit, 60±2mm Long, 4.8±0.2mm Height, green
• 66925776119304: Loading Unit, 60±2mm Long, 2.5±0.2mm Height, white
• 16925776119293: Linear Cutter Staplers, 100±2mm Length, green
• 16925776119286: Linear Cutter Staplers, 80±2mm Length, Blue
• 16925776119279: Linear Cutter Staplers, 60±2mm Length, white