Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason)

Basic Information

• Brand Name: Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason)
• Primary DI: 04260223141775
• Version / Model: 100734
• Company Name: PATH medical GmbH
• Labeler DUNS: 551540334
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1ccc3a7d-0524-49f1-9cab-a36fb7ea46fb
• Distribution End Date: 2017-01-25

Device Description

Content: 1. Earplugs 5-8 mm PM105 2. Earplugs 6 mm PM006 3. Earplugs 7 mm PM007 4. Earplugs 8 mm PM008 5. Earplugs 9 mm PM009 6. Earplugs 10 mm PM010 7. Earplugs 16 mm PM016 8. Earplugs 11-15 mm PM111 9. Earplugs 18,5 mm PM018 10. Earplugs 7-11 mm PM107 11. Earplugs 11 mm PM011 12. Earplugs 12 mm PM012 13. Earplugs 13 mm PM013 14. Earplugs 14 mm PM014 PATH MEDICAL is not manufacturer or Labeler of this product. The legal manufacturer confirmed to submit his UDI once stablished.

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: No
• 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	04260223141775	GS1