Duns Number:134614411
Device Description: Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSITE, Inc. C10-3 tr Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSITE, Inc. C10-3 transducers
Catalog Number
P27063-01
Brand Name
Needle Guide Bracket
Version/Model Number
P27063-01
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
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
d82c2f4e-9b11-46ad-8574-17ae75aa6c73
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 20, 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 |