Duns Number:007198742
Device Description: Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle e Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear while creating an avenue passage for air pressure equalization on either side of the drum.
Catalog Number
-
Brand Name
PAPARELLA 2000 VENT TUBE 60 PACK 114MM ID ULTRASIL SOFT SILICONE WITH TAB
Version/Model Number
70245756
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 07, 2017
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
K932166,K932166,K932166
Product Code
ETD
Product Code Name
Tube, Tympanostomy
Public Device Record Key
50e2b675-947a-47bb-932c-7f06d6bfba0f
Public Version Date
October 06, 2022
Public Version Number
5
DI Record Publish Date
October 24, 2015
Package DI Number
00821925026612
Quantity per Package
60
Contains DI Package
00821925039728
Package Discontinue Date
December 07, 2017
Package Status
Not 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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |