Duns Number:134614411
Device Description: Sterile needle guide with (14x91.5cm) CIV-Flex cover for use with Hitachi C23 and C23RV tr Sterile needle guide with (14x91.5cm) CIV-Flex cover for use with Hitachi C23 and C23RV transducer
Catalog Number
644-094, 644-094-5
Brand Name
BX2 Needle Guide
Version/Model Number
644-094
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
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
K093713,K093713,K093713
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
9c0b233a-2934-4a2d-aa41-55901c2e22f1
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
January 21, 2021
Package DI Number
00841436120050
Quantity per Package
12
Contains DI Package
10841436120057
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |