HERizon Disposable Endoscopic Forceps - Foreign Body Grasper

Basic Information

• Brand Name: HERizon Disposable Endoscopic Forceps - Foreign Body Grasper
• Primary DI: 00850033976281
• Version / Model: JY-C-350-18-S
• Catalog Number: JY-C-350-18-S
• Company Name: Minerva Surgical, Inc.
• Labeler DUNS: 829616478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-07
• Public Version: 1
• Public Version Date: 2024-10-15
• Public Version Status: New
• Public Device Record Key: a8717a47-79ae-4ef6-a72e-989a15a7ebb6

Device Description

Disposable Endoscopic Forceps - Foreign Body Grasper

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: 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: Yes
• 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
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46228	Rigid endoscopic biopsy forceps, single-use	A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850033976288	GS1	box	10	In Commercial Distribution
Primary	00850033976281	GS1
Package	20850033976285	GS1	shipping box	10	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity