ENDOPATH XCEL B12LTH

GUDID 30705036001175

Endopath XCEL Bladeless Trocars with Stability Sleeves

ETHICON ENDO-SURGERY, LLC

Laparoscopic access cannula, single-use

• Primary Device ID: 30705036001175
• NIH Device Record Key: ecb4e37f-f3f5-4f85-b02d-1584349db744
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPATH XCEL
• Version Model Number: B12LTH
• Catalog Number: B12LTH
• 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	10705036001171 [Unit of Use]
GS1	20705036001178 [Primary]
GS1	30705036001175 [Package]; Contains: 10705036001171; Package: CASE [36 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]

• 30705036002301: Endopath XCEL Dilating Tip Trocar Paks containing: 1 Dilating Tip trocar and 1 Universal Trocar
• 30705036002295: Endopath XCEL Dilating Tip Trocar Paks containing: 1 Dilating Tip trocar and 1 Universal Trocar
• 30705036002288: Endopath XCEL Dilating Tip Trocar Paks containing: 1 Dilating Tip trocar with Stability Sleeve a
• 30705036002271: Endopath XCEL Dilating Tip Trocar Paks containing: 1 Dilating Tip trocar and 1 Universal Trocar
• 30705036002011: Endopath XCEL Blunt Tip Trocars with Smooth Sleeves
• 30705036001601: Endopath XCEL Dilating Tip Trocars with Stability Sleeves
• 30705036001595: Endopath XCEL Dilating Tip Trocars with Stability Sleeves
• 30705036001588: Endopath XCEL Dilating Tip Trocars with Stability Sleeves
• 30705036001571: Endopath XCEL Dilating Tip Trocars with Stability Sleeves
• 30705036001564: Endopath XCEL Dilating Tip Trocars with Stability Sleeves
• 30705036001359: ENDOPATH XCEL Universal Trocar Stablility Sleeves
• 40705036001349: ENDOPATH XCEL Universal Trocar Stablility Sleeves
• 30705036001335: ENDOPATH XCEL Universal Trocar Stablility Sleeves
• 30705036001328: ENDOPATH XCEL Universal Trocar Stablility Sleeves
• 30705036001250: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001243: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001236: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 40705036001226: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001205: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001199: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001182: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001175: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001168: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001151: Endopath Xcel Bladeless Trocars with Smooth Sleeves
• 30705036001144: Endopath XCEL Bladeless Trocars with Smooth Sleeves
• 30705036001137: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001120: Endopath XCEL Bladeless Trocars with Stability Sleeves
• 30705036001113: Endopath Xcel Bladeless Trocars with Smooth Sleeves
• 30705036001106: Endopath XCEL Bladeless Trocars with Smooth Sleeves