Duns Number:745595413
Device Description: PATHFINDER 900 PLUS DDAS AUTOMATED TUBE MANAGEMENT SYSTEM FOR HIGH SPEED DECAPPING, ALIQUO PATHFINDER 900 PLUS DDAS AUTOMATED TUBE MANAGEMENT SYSTEM FOR HIGH SPEED DECAPPING, ALIQUOTING AND SORTING, SET UP FOR 20 INPUT/OUTPUT POSITIONS
Catalog Number
06R6103
Brand Name
PATHFINDER
Version/Model Number
PS-U-A1203
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
-
Product Code
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
06a1ab14-12e9-40bf-9d35-e4553f2e377d
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
November 16, 2020
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 | 15 |