Duns Number:595138793
Device Description: transducer holder
Catalog Number
682103
Brand Name
TA9007 TRANSDUCER HOLDER
Version/Model Number
682103
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
f98fe740-d2bc-432b-9271-643315cc4b30
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50886333621038
Quantity per Package
100
Contains DI Package
00886333621033
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Zip Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |