Duns Number:157412271
Device Description: Miracle-Ear HA ME 5300 MINI RIC PRL Hearing Aid
Catalog Number
10829201
Brand Name
Miracle-Ear
Version/Model Number
HA ME 5300 MINI RIC PRL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2020
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ESD
Product Code Name
Hearing Aid, Air Conduction
Public Device Record Key
e8ea85ff-85be-4ba2-a4d6-ca5d8e62eb03
Public Version Date
December 01, 2020
Public Version Number
4
DI Record Publish Date
May 06, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1885 |
2 | A medical device with a moderate to high risk that requires special controls. | 5568 |