Duns Number:140727624
Device Description: Single Action Biopsy Device 14g (2.1mm) x 9cm
Catalog Number
SABD-1409-15-T
Brand Name
Single Action Biopsy Device
Version/Model Number
SABD-1409-15-T
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
-
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
e20e328e-7e5f-4375-b6b6-f35760119373
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
20886333218589
Quantity per Package
10
Contains DI Package
00886333218585
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |