EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.

Basic Information

• Brand Name: EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.
• Primary DI: 00844505012263
• Version / Model: EE-0345
• Company Name: Grace Medical, Inc.
• Labeler DUNS: 030849173
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-05
• Public Version: 1
• Public Version Date: 2019-12-13
• Public Version Status: New
• Public Device Record Key: e3a618ee-7212-467c-94c6-0285ba8b4187

Device Description

EndoEar™ ENDOSCOPE 3.0 MM x 150 MM 45°

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44929	Otoscope, endoscopic	An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844505012263	GS1

Customer Contacts

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