Duns Number:429113525
Device Description: It's a special table on wheels for stereotactic breast biopsy procedures with patient in p It's a special table on wheels for stereotactic breast biopsy procedures with patient in prone position.
Catalog Number
6100-06M1
Brand Name
MAMMOBED
Version/Model Number
MAMMOBED
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
-
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
K925212,K925212
Product Code
IZH
Product Code Name
System, X-Ray, Mammographic
Public Device Record Key
b59145b2-50c2-4a9f-94b1-6bf4d726bea5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
18033837190308
Quantity per Package
1
Contains DI Package
08033837190301
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
X005778
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |