ENSEAL X1 NSLX120L

GUDID 20705036015021

ENSEAL 20 cm shaft, Large Jaw

ETHICON ENDO-SURGERY, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 20705036015021
• NIH Device Record Key: b5f9d939-ef79-49c0-8cf5-9a5e11b81183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENSEAL X1
• Version Model Number: NSLX120L
• Catalog Number: NSLX120L
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036015024 [Unit of Use]
GS1	20705036015021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163548

FDA Product Code

• HGI: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

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: 2019-07-08
• Device Publish Date: 2017-02-21

Devices Manufactured by ETHICON ENDO-SURGERY, LLC

• 20705036027857 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 100mm BLUE
• 30705036027861 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 100mm GREEN
• 20705036027871 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 60mm BLUE
• 40705036027882 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 60mm GREEN
• 30705036027892 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 80mm BLUE
• 30705036027908 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 80mm GREEN
• 30705036030878 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter 60mm
• 30705036030885 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter 80mm