Hobbs Medical Scope Introducer

Basic Information

• Brand Name: Hobbs Medical Scope Introducer
• Primary DI: M84946500
• Version / Model: 4650
• Catalog Number: 4650
• Company Name: HOBBS MEDICAL, INC.
• Labeler DUNS: 076769355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-14
• Public Version: 2
• Public Version Date: 2024-07-25
• Public Version Status: Update
• Public Device Record Key: ba2259d1-2e4f-453a-a253-5a21bb095497

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: 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
FGY	Cannula, Injection	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60758	Endoscope air/water valve, single-use	A device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M84946501	HIBCC	Box	5	In Commercial Distribution
Primary	M84946500	HIBCC

Customer Contacts

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