Duns Number:849234661
Device Description: Basic Biopsy Tray w/o Biopsy Needle
Catalog Number
600602
Brand Name
PercuSet Basic Biopsy Tray
Version/Model Number
600602
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
-
Product Code
OJT
Product Code Name
Aspiration Tray
Public Device Record Key
36854ad6-dfdc-4125-837e-24006a6e7185
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 2022
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 28 |