Duns Number:030849173
Device Description: ARMSTRONG R VENT TUBE W/TAB 1.14 MM ID SILICONE 30 PACK
Catalog Number
-
Brand Name
ARMSTRONG R VENT TUBE
Version/Model Number
510-283
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K981575,K981575
Product Code
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
9ef68ae5-7098-47ab-9e9f-ca8b22f3923f
Public Version Date
December 13, 2021
Public Version Number
6
DI Record Publish Date
June 16, 2017
Package DI Number
10844505011171
Quantity per Package
30
Contains DI Package
00844505011174
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 |