Duns Number:134614411
Device Description: Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with Siemens EC7, EC9-4 (SONOLINE G20, G50, G60 S, X500) and EC-10C5 transducers
Catalog Number
612-051, 612-055
Brand Name
Needle Guide
Version/Model Number
612-051, 612-055
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K970514,K970514,K970514
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
c71a7fcb-bf55-4369-929a-79869558bc52
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104784
Quantity per Package
5
Contains DI Package
10841436104767
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 |