AccessGUDID - DEVICE: Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason) (04260223141775)

GUDID

Device Identifier (DI) Information

Brand Name: Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason)
Version or Model: 100734
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PATH medical GmbH

Primary DI Number: 04260223141775
Issuing Agency: GS1
Commercial Distribution End Date: January 25, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 551540334 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWJ	Stimulator, Auditory, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ccc3a7d-0524-49f1-9cab-a36fb7ea46fb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 2016