Duns Number:595138793
Device Description: holder
Catalog Number
682161
Brand Name
SP5555-POLE MOUNTING BRACKET
Version/Model Number
682161
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
KRB
Product Code Name
Probe, Thermodilution
Public Device Record Key
3d4b0234-5ebc-4d30-b492-a80dff8de700
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50886333621618
Quantity per Package
50
Contains DI Package
00886333621613
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 |