Duns Number:832696038
Device Description: ADJUSTABLE COAXIAL ACHIEVE NEEDLE BIOPSY 16G X 15CM
Catalog Number
ACA1615
Brand Name
ACHIEVE
Version/Model Number
ACA1615
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2017
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
GDF
Product Code Name
GUIDE, NEEDLE, SURGICAL
Public Device Record Key
fc950305-b67d-4f96-bc17-c9a59748f7a5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 16, 2017
Package DI Number
50885403222434
Quantity per Package
5
Contains DI Package
10885403222436
Package Discontinue Date
October 27, 2017
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |