Duns Number:134614411
Device Description: Reusable non-sterile AccuSITE™ bracket for use with Canon Medical Systems I9LX2 transducer Reusable non-sterile AccuSITE™ bracket for use with Canon Medical Systems I9LX2 transducers
Catalog Number
680-177
Brand Name
Biopsy Bracket
Version/Model Number
680-177
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
-
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
e3d9f225-00aa-405f-87c1-e1264491801c
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
June 23, 2021
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 |