Duns Number:043674543
Device Description: ENCOR® Probe Stereotactic/Ultrasound 7G
Catalog Number
ECP017G
Brand Name
ENCOR®
Version/Model Number
ECP017G
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
K051158,K051158
Product Code
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
d91cbc0f-b367-4839-a9f2-d23169152591
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10801741086288
Quantity per Package
5
Contains DI Package
00801741086281
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 |