SONTEC BLACK CASE

Basic Information

• Brand Name: SONTEC BLACK CASE
• Primary DI: 00192896071629
• Version / Model: C-079.05.000
• Catalog Number: C-079.05.000
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-10
• Public Version: 2
• Public Version Date: 2021-01-05
• Public Version Status: Update
• Public Device Record Key: 80c1236f-41e5-4a2d-ba0e-47293d809456
• Distribution End Date: 2021-01-04

Device Description

SONTEC BLACK CASE

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETF	UNIT, EXAMINING/TREATMENT, ENT	Ear, Nose, Throat	874.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60353	General physical examination set	A collection of hand-held devices, battery-powered but may include manual, intended to be used by a physician to help perform parts of a general physical examination of a patient [i.e., ear/nose/throat (ENT) and ophthalmic examinations, blood pressure measurements, temperature] commonly conducted in a primary care setting. The devices (e.g., aneroid sphygmomanometer, otoscope, ophthalmoscope, electronic thermometer) are typically housed within a line-powered charging station (e.g., desktop, wall-mounted) or carry case, which may include accessories (e.g., ear specula, spare light bulbs). This is a reusable device that may contain some disposable devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896071629	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	13	Inch
Length	16.25	Inch
Height	6	Inch