Duns Number:030849173
Device Description: SUPERSOFT™ T-TUBE 1.14MM ID X 8MM LENGTH SILICONE 5 PACK
Catalog Number
-
Brand Name
SUPERSOFT™ T-TUBE
Version/Model Number
510-361
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K830228,K830228
Product Code
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
bc2e4fa1-e552-4b0e-8027-4f92a45d064a
Public Version Date
January 22, 2021
Public Version Number
2
DI Record Publish Date
November 11, 2019
Package DI Number
10844505012628
Quantity per Package
5
Contains DI Package
00844505012621
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 |