Duns Number:134614411
Device Description: Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 29.2cm) C Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens L13-5 transducers
Catalog Number
11001907
Brand Name
Biopsy Starter Kit
Version/Model Number
11001907
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
K093713,K093713
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
6f2a6e45-4c78-4c2e-86fc-1ca99a9bf548
Public Version Date
June 10, 2022
Public Version Number
10
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 |