Duns Number:361092450
Device Description: TruDi NAV Cable - 1PK
Catalog Number
TDNC001Z
Brand Name
TruDi NAV Cable
Version/Model Number
TDNC001Z
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K180948
Product Code
PGW
Product Code Name
Ear, Nose, and Throat Stereotaxic Instrument
Public Device Record Key
7063249d-302c-4eeb-9765-235689a9f6fa
Public Version Date
January 22, 2020
Public Version Number
2
DI Record Publish Date
October 31, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 83 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |