Duns Number:078763316
Device Description: 3M(TM) E-A-RLINK(TM) Foam plug-with-hole 1/2 inch height, 0.100 in hole 5C 420-2036, 10,00 3M(TM) E-A-RLINK(TM) Foam plug-with-hole 1/2 inch height, 0.100 in hole 5C 420-2036, 10,000/case
Catalog Number
420-2036
Brand Name
E-A-RLINK™
Version/Model Number
420-2036
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
2de8650b-03cf-4f88-8fab-790b6f516cff
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 05, 2017
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |