Duns Number:801895244
Device Description: Lumax TS Pro Fiberoptic Transmission Cable Reusable • Length: 44" (112 cm)
Catalog Number
-
Brand Name
Lumax TS Pro
Version/Model Number
10310-000
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
-
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
K953734
Product Code
FEN
Product Code Name
Device, Cystometric, Hydraulic
Public Device Record Key
8d381a39-8586-4741-b666-98ccb9ec5fd2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 11, 2016
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |