Duns Number:043674543
Device Description: ENCOR® Breast Biopsy System Tissue Collection Tray
Catalog Number
ECTT
Brand Name
ENCOR®
Version/Model Number
ECTT
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
-
Product Code
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
cc4388b5-1c2b-4edc-a1cb-f7c861a8f5d1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
10801741086417
Quantity per Package
5
Contains DI Package
00801741086410
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |