Senhance 200-11096

GUDID 00815440021276

Fundus Grasper

TRANSENTERIX, INC.

Robotic surgical forceps

• Primary Device ID: 00815440021276
• NIH Device Record Key: 1d776bf6-0f3d-42e2-b19c-a99cc621773d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senhance
• Version Model Number: X0007037
• Catalog Number: 200-11096
• Company DUNS: 969118900
• Company Name: TRANSENTERIX, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 240 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815440021276 [Primary]

FDA Product Code

• NAY: System, Surgical, Computer Controlled Instrument

Sterilization

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

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

[00815440021276]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-02

On-Brand Devices [Senhance]

• 00815440021696: Bipolar Curved Scissors
• 00815440021689: Bipolar Maryland Dissector
• 00815440021672: Bipolar Curved Grasping Forceps
• 00815440021665: Bipolar Large Grasping Forceps
• 00815440021658: Bipolar Shaft
• 00815440021498: Adapter, Bipolar Curved Scissors
• 00815440021481: Adapter, Bipolar Maryland Dissector
• 00815440021474: Adapter, Bipolar Curved Grasping Forceps
• 00815440021467: Adapter, Bipolar Large Grasping Forceps
• 00815440021429: Adapter, Passive Weck® Hem-o-lok® ML Clip Applier
• 00815440021412: Adapter, Passive Fundus Grasper
• 00815440021399: Adapter, Monopolar Maryland Dissector
• 00815440021382: Adapter, Monopolar Metzenbaum Scissors 15 mm Tip
• 00815440021375: Adapter, Monopolar Metzenbaum Scissors 18 mm Tip
• 00815440021368: Adapter, Passive Needle Holder Left
• 00815440021351: Adapter, Passive Needle Holder Right
• 00815440021344: Adapter, Passive Babcock Forceps
• 00815440021337: Adapter, Passive Mixter Dissector
• 00815440021320: Adapter, Passive Strong Grasper
• 00815440021313: Adapter, Passive Johan Grasper 15 mm Tip
• 00815440021306: Adapter, Passive Allis Grasper
• 00815440021283: Weck® Hem-o-lok® ML Clip Applier
• 00815440021276: Fundus Grasper
• 00815440021252: Monopolar Maryland Dissector
• 00815440021245: Monopolar Metzenbaum Scissors 15 mm Tip
• 00815440021238: Monopolar Metzenbaum Scissors 18 mm Tip
• 00815440021221: Needle Holder Left
• 00815440021214: Needle Holder Right
• 00815440021207: Babcock Forceps
• 00815440021191: Mixter Dissector
• 00815440021184: Strong Grasper
• 00815440021177: Kocher Grasper
• 00815440021160: Adapter, Passive Kocher Grasper
• 00815440021153: Johan Grasper 15 mm Tip
• 00815440021146: Allis Grasper
• 00815440021115: Senhance System Power Pack (US)
• 00815440021108: Senhance Manipulator Arm
• 00815440021092: NOVADAQ 10 mm Endoscope Adapter
• 00815440021085: NOVADAQ 5 mm Endoscope Adapter
• 00815440021078: Stryker Advanced Imaging 5 mm Endoscope Adapter
• 00815440021061: CONMED 3DHD 10 mm Endoscope Adapter
• 00815440020996: Adapter, Passive Needle Holder Straight
• 00815440020965: Adapter, Monopolar Curved Metzenbaum Scissors
• 00815440020941: Adapter, Monopolar Maryland Dissector
• 00815440020927: Adapter, Passive DeBakey Grasper
• 00815440020903: Adapter, Passive Cobra Grasper
• 00815440020880: Adapter, Passive Atraumatic Single Action Grasper
• 00815440020866: Adapter, Bipolar Maryland Dissector
• 00815440020859: Adapter, Bipolar Curved Scissors
• 00815440020842: Adapter, Bipolar Curved Grasping Forceps