Manus Medical, LLC

Basic Information

• Brand Name: Manus Medical, LLC
• Primary DI: 00811870037702
• Version / Model: ANM-20154
• Company Name: Manus Medical, LLC
• Labeler DUNS: 800604196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-29
• Public Version: 1
• Public Version Date: 2023-10-09
• Public Version Status: New
• Public Device Record Key: de2eb617-5e6e-4d36-9e51-f5a519eacdcd

Device Description

STERILE VIENNA SPECULUM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EPY	Speculum, Ent	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32790	Nasal snare, single-use	A hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811870037706	GS1		50	In Commercial Distribution
Primary	00811870037702	GS1