Duns Number:134614411
Device Description: Reusable non-sterile position sensor mount multi-angle brackets (4) with Ultra-Pro II™ Nee Reusable non-sterile position sensor mount multi-angle brackets (4) with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare 9L, C1-5, ML6-15 and S1-5 Volume Navigation transducers
Catalog Number
5304800-2
Brand Name
Biopsy Starter Kit
Version/Model Number
5304800-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 05, 2021
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
K092619,K092619,K092619
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
8b09248c-d0c1-4be7-b67e-9257d2b2554c
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
August 22, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |