Duns Number:030370299
Device Description: Breast Biopsy Tray
Catalog Number
CUS445
Brand Name
Integra®
Version/Model Number
CUS445
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K960248,K960248,K960248
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
0fc1ff87-7701-408f-b3fd-9ccd65cc65e2
Public Version Date
July 23, 2018
Public Version Number
1
DI Record Publish Date
June 20, 2018
Package DI Number
30381780431279
Quantity per Package
10
Contains DI Package
10381780431275
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 261 |