Duns Number:201740425
Device Description: ER-3A insert earphones for use as an accessory with the second generation Integrity V500 s ER-3A insert earphones for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
Catalog Number
-
Brand Name
Integrity Insert Earphones
Version/Model Number
ER-3A-800
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043396
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
f68f3609-6459-4543-ab3e-c5607dd920a2
Public Version Date
April 21, 2020
Public Version Number
4
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |