Duns Number:827693503
Device Description: Assure Speaker-In-Ear Style 48WL Black
Catalog Number
HLT-SIE48WL-BK
Brand Name
Assure®
Version/Model Number
2360 WL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
OSM
Product Code Name
Hearing aid, air conduction with wireless technology
Public Device Record Key
272a7e92-9f02-455c-94d9-4da3089ef0d9
Public Version Date
October 06, 2020
Public Version Number
6
DI Record Publish Date
December 30, 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 | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 352 |