Duns Number:092987189
Device Description: Vent Tube Armstrong 1.14mm Tab Pair
Catalog Number
S381516 2
Brand Name
NeoZoline
Version/Model Number
S381516 2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
ETD
Product Code Name
Tube, Tympanostomy
Public Device Record Key
e29c2fa0-6a4b-43d6-9cef-5f69a19a5b7e
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
October 15, 2015
Package DI Number
M63338151623
Quantity per Package
10
Contains DI Package
M633S38151622
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 | 871 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 127 |
| U | Unclassified | 11 |