ENDOPATH DEXTRUS FLR03

GUDID 30705036001984

Endopath Dextrus Fixed-Length Access Retractors Large(Greater than 7cm abdominal thickness)

ETHICON ENDO-SURGERY, LLC

Radial surgical retractor

• Primary Device ID: 30705036001984
• NIH Device Record Key: 19f4412a-b39a-4095-9dcf-4afac3b31d28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPATH DEXTRUS
• Version Model Number: FLR03
• Catalog Number: FLR03
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036001980 [Unit of Use]
GS1	20705036001987 [Primary]
GS1	30705036001984 [Package]; Contains: 20705036001987; Package: CASE [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070198

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [ENDOPATH DEXTRUS]

• 30705036002059: Endopath Dextrus Seal Cap Assembly with Accessories (Marking Pen, Ruler, and Forearm Wrap)
• 30705036001984: Endopath Dextrus Fixed-Length Access Retractors Large(Greater than 7cm abdominal thickness)
• 30705036001977: Endopath Dextrus Fixed-Length Access Retractors Medium (4 to 7cm abdominal thickness)
• 30705036001960: Endopath Dextrus Fixed-Length Access Retractors Small (up to 4cm abdominal thickness)