Minerva Single Sterile Disposable Handpiece

Basic Information

• Brand Name: Minerva Single Sterile Disposable Handpiece
• Primary DI: 00862393000162
• Version / Model: MIN9770
• Catalog Number: MIN9770
• Company Name: Minerva Surgical, Inc.
• Labeler DUNS: 829616478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-27
• Public Version: 11
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 624596b2-b2d6-44c1-a98d-e6897c7fd730

Device Description

STERILE MINERVA Disposable Handpiece Contents: (1) One Single use STERILE Minerva ES Disposable Handpiece (1) One Single Use STERILE Syringe (1) One Single Use STERILE 8mm Hegar Dilator (1) One Single use NON-STERILE Desiccant (1) One NON-STERILE Handpiece Instructions For Use (1) One NON-STERILE Dilator Instructions For Use

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
MNB	Device, Thermal Ablation, Endometrial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62227	Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument	A flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by gas plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to a parent device (i.e., inert gas-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include controls. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862393000162	GS1
Package	00862393000117	GS1	Box	3	In Commercial Distribution

Customer Contacts

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