Duns Number:184763290
Catalog Number
2N2702X/B
Brand Name
Tru-Cut®
Version/Model Number
10884450443023
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
Yes
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
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
cba272b5-b93e-4eb3-99e3-6b6c3b26ac6a
Public Version Date
June 03, 2020
Public Version Number
1
DI Record Publish Date
May 26, 2020
Package DI Number
20884450443020
Quantity per Package
2
Contains DI Package
10884450443023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |