Senti Set 3

Basic Information

• Brand Name: Senti Set 3
• Primary DI: 04260223142970
• Version / Model: 100460
• Company Name: PATH medical GmbH
• Labeler DUNS: 551540334
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-14
• Public Version: 3
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 70a40667-0b59-4e96-af47-24fcc185a2ea
• Distribution End Date: 2020-01-20

Device Description

Senti Audiometry (Class 3 with HF) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Pure Tone Audiometer High Frequency AN100454 7. Headphone HDA-300 AN100630 8. Bone conductor B-71 with Patient Response button AN100214 9. Power supply AN100083 10. USB data cable AN100089

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37503	Tone audiometer	An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260223142970	GS1