OMNI

Basic Information

• Brand Name: OMNI
• Primary DI: 15420045515734
• Version / Model: OMNI-G-001
• Catalog Number: OMNI-G-001
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-19
• Public Version: 1
• Public Version Date: 2024-02-27
• Public Version Status: New
• Public Device Record Key: 371072d2-b53d-41d4-a62c-bf4012bcc8b2

Device Description

The Omni Hysteroscopic Grasper is a sterile, single-use, hand actuated hysteroscopic grasper that is intended to be used by a trained gynecologist to provide traction of soft intrauterine tissue.

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NWW	Hysteroscope accessories	Obstetrics/Gynecology	884.1690	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61839	Rigid endoscopic tissue manipulation forceps, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045515734	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]