Accessory box AB-LT01

Basic Information

• Brand Name: Accessory box AB-LT01
• Primary DI: 04260223144912
• Version / Model: 101043
• Company Name: PATH medical GmbH
• Labeler DUNS: 551540334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-14
• Public Version: 3
• Public Version Date: 2024-01-22
• Public Version Status: Update
• Public Device Record Key: 805c3fac-08b0-46e0-a384-de603bd256b4

Device Description

Accessory Set including: 5pcs. 101014 Probe Tip PT-LT 1pc. 100160 Test Cavity PT-S 10pcs. 101035 Ear Tip Soft ET-LT10F 10pcs. 101036 Ear Tip Soft ET-LT14F 10pcs. 101037 Ear Tip ET-LT35 10pcs. 101038 Ear Tip ET-LT40 10pcs. 101311 Ear Tip ET-LT8T 10pcs. 101312 Ear Tip ET-LT13T 10pcs. 101365 Ear Tip ET-LT40G 15pcs. 101366 Ear Tip ET-LT45G 15pcs. 101367 Ear Tip ET-LT50G 10pcs. 101368 Ear Tip ET-LT60M 3pcs. 100186 Filter disk 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	04260223144912	GS1