Duns Number:481999654
Device Description: Triangle Blade
Catalog Number
3054-6
Brand Name
ENDOTRAC
Version/Model Number
3054-6
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
K940230,K940230
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
adfcd1a3-d861-456e-9d53-718312d8eee8
Public Version Date
January 22, 2021
Public Version Number
5
DI Record Publish Date
November 28, 2017
Package DI Number
37613327364348
Quantity per Package
6
Contains DI Package
07613327364347
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2606 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9953 |
| 3 | A medical device with high risk that requires premarket approval | 186 |