Accessory box AB03

Basic Information

• Brand Name: Accessory box AB03
• Primary DI: 04260223140730
• Version / Model: 100261
• Company Name: PATH medical GmbH
• Labeler DUNS: 551540334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e58f9f72-82ab-4409-9e34-8a4c2e406c65

Device Description

Accessory Set including: 4pcs. 100013 Probe Tip PT-A 4pcs. 100014-W Probe Tip PT-S 1pc. 100129 Test Cavity PT-A 1pc. 100160 Test Cavity PT-S 10pcs. 100063 Ear Tip ET-03 10pcs. 100064 Ear Tip ET-10 7pcs 100125 Ear Tip ET-11 5pcs. 100839 Ear Tip Soft ET-17 6pcs. 100838 Ear Tip Soft ET-16 10pcs. 100144 Ear Tip ET-13 4pcs. 100230 Ear Tip Soft ET-14 10pcs. 100030 Ear Tip ET-S02 10pcs. 100031 Ear Tip ET-S03 10pcs. 100032 Ear Tip ET-S10 10pcs. 100840 Ear Tip Soft ET-S11 1pc. 100151 Cleaning Tool CT-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWJ	Stimulator, Auditory, Evoked Response	Neurology	882.1900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35747	Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260223140730	GS1