The Omni Hysteroscopic Grasper is a sterile, single
OMNI - OMNI-G-001
Device Description
A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NWW
Device Name: Hysteroscope Accessories
Device Class: 1
Physical State: Metal instruments
Definition: Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
Submission Type ID: 4
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Part of system that advances through the working channel of the hysteroscope to perform it's function.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Uterus
Regulation Number: 884.1690
Third Party Flag: N
Medical Specialty: OB
Device IdentifiersDevice Id: 15420045515734
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A