Duns Number:134614411
Device Description: Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guide Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex™ covers (5) for use with SonoSite L25 transducers (18 GA)
Catalog Number
P12920-03
Brand Name
Needle Guide Starter Kit
Version/Model Number
P12920-03
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
K030064,K030064
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
fd6570b6-afd7-4536-af06-3658d56098dd
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
June 21, 2019
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 |