Duns Number:006261481
Device Description: TRANSDUCER 95184-002 BIO-PROBE TX-50 FA
Catalog Number
-
Brand Name
NA
Version/Model Number
95184-002
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K924208
Product Code
DPT
Product Code Name
PROBE, BLOOD-FLOW, EXTRAVASCULAR
Public Device Record Key
72c58cff-39b4-4206-9d0e-1748937719d1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |