Duns Number:835465063
Device Description: VENT TUBE 1066016 10PK PAIR T TUBE 1.14
Catalog Number
-
Brand Name
T-Tube® C-Flex®
Version/Model Number
1066016
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
K151067,K151067
Product Code
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
57338897-709d-450f-9391-dff33d1df2d2
Public Version Date
January 22, 2021
Public Version Number
2
DI Record Publish Date
December 17, 2020
Package DI Number
20763000282756
Quantity per Package
10
Contains DI Package
00763000282752
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |