Duns Number:001292192
Device Description: NEEDLE BIOPSY S/SU 20GA 3-1/2IN BREAST
Catalog Number
409407
Brand Name
BD PrecisionGlide
Version/Model Number
409407
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
K881697,K881697,K881697
Product Code
IZH
Product Code Name
System, x-ray, mammographic
Public Device Record Key
dfb9f925-dd21-4d77-9294-146a0f397342
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50382904094077
Quantity per Package
5
Contains DI Package
30382904094073
Package Discontinue Date
-
Package Status
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |