Duns Number:078763316
Device Description: 3M(TM) E-A-RLINK(TM) 3A Foam Eartip adult size, yellow, with black tube 420-2004, 500/case
Catalog Number
420-2004
Brand Name
E-A-RLINK™
Version/Model Number
420-2004
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ETT
Product Code Name
CUSHION, EARPHONE (FOR AUDIOMETRIC TESTING)
Public Device Record Key
11f9ea50-bdef-407e-bdce-d092d80da75e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10080529510133
Quantity per Package
10
Contains DI Package
00080529510136
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |