Duns Number:832696038
Device Description: WINGLESS ACHIEVE NEEDLE BIOPSY 14G X 11CM
Catalog Number
WA1411
Brand Name
ACHIEVE
Version/Model Number
WA1411
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 06, 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
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
bed1dd71-024e-45d7-ae62-5b0251273930
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 30, 2016
Package DI Number
50885403222298
Quantity per Package
5
Contains DI Package
10885403222290
Package Discontinue Date
September 06, 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 |