Duns Number:092987189
Device Description: Vent Tube Armstrong 1.14mm Tab Each
Catalog Number
S381512
Brand Name
NeoZoline
Version/Model Number
S381512
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
922c70e3-7784-45dd-859b-0952935bfa2a
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
October 15, 2015
Package DI Number
M6333815121
Quantity per Package
10
Contains DI Package
M633S3815120
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 |