Senhance

Basic Information

• Brand Name: Senhance
• Primary DI: 00815440021283
• Version / Model: X0007040
• Catalog Number: 230-11018
• Company Name: Asensus Surgical, Inc.
• Labeler DUNS: 969118900
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-02
• Public Version: 3
• Public Version Date: 2022-07-11
• Public Version Status: Update
• Public Device Record Key: cf40ee8f-4ff0-43b4-9fb7-245f5abb540b

Device Description

Weck® Hem-o-lok® ML Clip Applier

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63113	Robotic surgical forceps, reusable	A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815440021283	GS1

Device Sizes

Type	Value	Unit	Text
Length	240	Millimeter
Outer Diameter	5	Millimeter