Duns Number:030849173
Device Description: ARMSTRONG X BEVELED GROMMET 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
Catalog Number
-
Brand Name
ARMSTRONG X VENT TUBE
Version/Model Number
525-201
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062385,K062385
Product Code
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
0fc56ed7-ca68-4559-8643-1b6b7be7072f
Public Version Date
January 22, 2021
Public Version Number
5
DI Record Publish Date
February 18, 2016
Package DI Number
10844505008492
Quantity per Package
5
Contains DI Package
00844505008495
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 200 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 564 |