AccessGUDID - DEVICE: Sonopal® soft Lacquer E (E239M1115071)

GUDID

Device Identifier (DI) Information

Brand Name: Sonopal® soft Lacquer E
Version or Model: M111507
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M111507
Company Name: Innovation MediTech GmbH

Primary DI Number: E239M1115071
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313785693 *Terms of Use

Device Description: No.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
41228	Earmould, custom-made	A custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ESD	Hearing aid, air conduction

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 18 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad269910-7334-41c8-9fc3-bcb3ddfd9e9c
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020