OSSEOUS Jobson Horne Probe-Oval

Basic Information

• Brand Name: OSSEOUS Jobson Horne Probe-Oval
• Primary DI: 08906039319637
• Version / Model: EI0963
• Company Name: EON MEDITECH PRIVATE LIMITED
• Labeler DUNS: 930270428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-04
• Public Version: 1
• Public Version Date: 2024-07-12
• Public Version Status: New
• Public Device Record Key: a9677356-ba35-4a53-85e0-89c58c894cb6

Device Description

"Jobson Horne Probe and Cerumen hook are used to hook out wax or foreign bodies from the ear canal. "

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: Yes
• 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
JYG	Curette, Ear	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63656	Abdominal/ENT/orthopaedic surgical probe, single-use	A slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08906039318173	GS1	Laminated Box	100	In Commercial Distribution
Primary	08906039319637	GS1

Device Sizes

Type	Value	Unit	Text
Length	152	Millimeter
Length	2.80	Millimeter
Width	1.34	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius