Duns Number:030849173
Device Description: TOUMA VENT TUBE W/TAB 1.14MM ID PC SILICONE, 50 DUROMETER 5 PACK
Catalog Number
-
Brand Name
TOUMA VENT TUBE W/TAB
Version/Model Number
510-521C
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
K062672,K062672
Product Code
ETD
Product Code Name
Tube, Tympanostomy
Public Device Record Key
dd11fbd4-f1bc-4697-89b5-e70dd2263157
Public Version Date
January 22, 2021
Public Version Number
6
DI Record Publish Date
January 03, 2018
Package DI Number
10844505011577
Quantity per Package
5
Contains DI Package
00844505011570
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 |