Duns Number:940023385
Device Description: PreciseCore Biopsy 14 ga x 10 cm 10 mm notch
Catalog Number
-
Brand Name
Inrad
Version/Model Number
671014
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093399,K093399
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
6ae78855-e19a-4354-ae1a-9654337ccadb
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
December 01, 2016
Package DI Number
10817295020753
Quantity per Package
5
Contains DI Package
00817295020756
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |