ENDOPATH XCEL OPTIVIEW 2D5LT

GUDID 30705036013758

Endopath Xcel with OPTIVIEW Technology Dilating Tip Trocars with Stability Sleeves

ETHICON ENDO-SURGERY, LLC

Laparoscopic access cannula, single-use

• Primary Device ID: 30705036013758
• NIH Device Record Key: 927c8547-6a6e-4d39-a769-ae851a89bcc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPATH XCEL OPTIVIEW
• Version Model Number: 2D5LT
• Catalog Number: 2D5LT
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036013754 [Unit of Use]
GS1	20705036013751 [Primary]
GS1	30705036013758 [Package]; Contains: 10705036013754; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032676

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-07-15

On-Brand Devices [ENDOPATH XCEL OPTIVIEW]

• 30705036014274: Endopath Xcel with OPTIVIEW Technology Bladeless Trocars with Stability Sleeves
• 30705036014267: Endopath Xcel with OPTIVIEW Technology Universal Trocar Stability Sleeves
• 30705036014250: Endopath Xcel with OPTIVIEW Technology Blunt Tip Trocars with Smooth Sleeves
• 30705036014243: Endopath Xcel with OPTIVIEW Technology Dilating Tip Trocars with Stability Sleeves
• 30705036014236: Endopath Xcel with OPTIVIEW Technology Dilating Tip Trocars with Stability Sleeves
• 30705036014212: Endopath Xcel with OPTIVIEW Technology Bladeless Trocars with Stability Sleeves
• 30705036013765: Endopath Xcel with OPTIVIEW Technology Dilating Tip Trocars with Stability Sleeves
• 30705036013758: Endopath Xcel with OPTIVIEW Technology Dilating Tip Trocars with Stability Sleeves
• 30705036013741: Endopath Xcel with OPTIVIEW Technology Universal Trocar Stability Sleeves
• 30705036013734: Endopath Xcel with OPTIVIEW Technology Universal Trocar Stability Sleeves
• 30705036013727: Endopath Xcel with OPTIVIEW Technology Bladeless Trocars with Stability Sleeves
• 30705036013710: Endopath Xcel with OPTIVIEW Technology Bladeless Trocars with Stability Sleeves
• 30705036013703: Endopath Xcel with OPTIVIEW Technology Bladeless Trocars with Stability Sleeves