ENDOPATH 355HR

GUDID 30705036000451

Endopath Trocar Sleeve Housings for the Endopath Resposable Trocar System

ETHICON ENDO-SURGERY, LLC

Laparoscopic access cannula, single-use

• Primary Device ID: 30705036000451
• NIH Device Record Key: 67e1f28f-29c4-40f0-8223-49b7a613171c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPATH
• Version Model Number: 355HR
• Catalog Number: 355HR
• 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
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• 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	10705036000457 [Unit of Use]
GS1	20705036000454 [Primary]
GS1	30705036000451 [Package]; Contains: 20705036000454; Package: CASE [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971738

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: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-07-15

On-Brand Devices [ENDOPATH]

• 30705036013857: Endopath Bipolar Active/Return Cord with Fixed Pin Connector 1.12 inch (28.5mm)
• 30705036013420: Endopath Ultra Veress Insufflation Needles with Luer Lock Connectors
• 30705036013376: Endopath Surgical Thoracic Trocar Sleeves with Rounded Tip Obturator
• 40705036013366: Endopath ETS- Endoscopic Linear Cutter, 35mm
• 40705036013359: Endopath ETS- Endoscopic Linear Cutter, 35mm
• 40705036012970: Endopath Pneumoneedle Insufflation Needles with Luer Lock Connectors 150mm
• 40705036012963: Endopath Pneumoneedle Insufflation Needles with Luer Lock Connectors 120mm
• 40705036012574: Endopath Electrosurgery Probe Plus II 5mm Accessory Port Suction and Irrrigation Shafts with Acc
• 30705036012553: Endopath Electrosurgery Probe Plus II 10mm Suction and Irrrigation Shafts - Use only with Probe
• 30705036012515: Endopath Electrosurgery Probe Plus II 5mm Right Angle Monopolar Electrosurgery Suction and Irrri
• 40705036012505: Endopath Electrosurgery Probe Plus II 5mm Spatula Monopolar Electrosurgery Suction and Irrrigati
• 30705036012492: Endopath Electrosurgery Probe Plus II 5mm Hook Monopolar Electrosurgery Suction and Irrrigation
• 40705036012482: Endopath Electrosurgery Probe Plus II 5mm Curved Dissector Monopolar Electrosurgery Suction and
• 40705036012475: Endopath Electrosurgery Probe Plus II 5mm Right Angle Monopolar Electrosurgery Suction and Irrri
• 40705036012468: Endopath Electrosurgery Probe Plus II 5mm Spatula Monopolar Electrosurgery Suction and Irrrigati
• 40705036012451: Endopath Electrosurgery Probe Plus II 5mm Hook Monopolar Electrosurgery Suction and Irrrigation
• 40705036012444: Endopath Electrosurgery Probe Plus II Pistol Hand Control Pistol Grip Handles with Suction and I
• 40705036012437: Endopath Electrosurgery Probe Plus II Pistol Foot Control Pistol Grip Handles with Suction and I
• 40705036012321: Endopath ETS Flex Endoscopic Articulating Linear Cutter, Vascular/Thin
• 40705036012314: Endopath ETS Flex Endoscopic Articulating Linear Cutter
• 40705036012284: Endopath Dilating Tip Trocars
• 10705036012245: Endopath Reusable Trocar Stability Sleeve for the Endopath Resposable System
• 40705036012192: Endopath Blunt Tip Obturator and Housing Assemblies and Adjustable Plugs for the Endopath Respos
• 10705036012153: Endopath Reusable Trocar Stability Sleeve for the Endopath Resposable System
• 10705036012047: Endopath Reusable Trocar Stability Sleeve for the Endopath Resposable System
• 10705036011972: Endopath Reusable Trocar Stability Sleeve for the Endopath Resposable System
• 40705036011942: ONESEAL Reducer Caps
• 30705036011891: Endopath Bipolar Forceps with Micro Jaw
• 30705036011884: Endopath Bipolar Forceps with Macro Jaw
• 30705036011877: ENDOPATH 5mm Endoscopic Blunt Tip Dissectors (12 Pouches Containing 3 Dissectors each)
• 30705036011860: ENDOPATH 10mm Endoscopic Blunt Cherry Dissectors (12 Pouches Containing 3 Dissectors each)
• 30705036004022: Endopath Bipolar Active/Return Cord with Coaxial Pin Connector
• 30705036003186: Endopath ETS45 2.5mm Reloads (Vascular/Thin)
• 30705036003179: Endopath ETS45 4.1mm Reloads (Thick)
• 30705036003155: Endopath ETS and ETS-Flex Articulating Endoscopic Linear Cutter Reload.
• 30705036003148: Endopath ETS and ETS-Flex Articulating Endoscopic Linear Cutter Reload.
• 30705036002745: Endopath ETS Compact-Flex45 Articulating Linear Cutter for Open Procedures
• 30705036002738: Endopath ETS Compact-Flex45 Articulating Linear Cutter for Open Procedures
• 30705036002530: Endopath ETS Flex45 No-Knife Endoscopic Articulating Linear Stapler, 45mm
• 30705036002523: Endopath ETS Flex45 No-Knife Endoscopic Articulating Linear Stapler, 45mm
• 30705036002424: ETS-Flex45 Endoscopic Articulating Long Linear Cutter, No Reload
• 30705036001878: Endopath Electrosurgery Probe Plus II Pencil Hand Control Pencil Grip Handles with Suction and I
• 30705036001861: Endopath Electrosurgery Probe Plus II Pencil Foot Control Pencil Grip Handles with Suction and I
• 30705036001540: Endopath ETS Compact-Flex45 Articulating Endoscopic Linear Cuter, No Cartridge
• 30705036001090: Endopath ETS Flex Endoscopic Articulating Linear Cutter, Vascular/Thin
• 30705036001083: Endopath ETS-Flex45 No-Knife Articulating Endoscopic Linear Stapler, No Reload
• 30705036001076: Endopath ETS-Flex45 Articulating Endoscopic Linear Cutter, No Reload
• 30705036001069: Endopath ETS Flex45 Endoscopic Articulating Linear Cutter, Thick
• 30705036000871: ETS-Flex45 Endoscopic Articulating Linear Cutter
• 30705036000857: GRAY CART RELOAD-LINEAR CUTTER