Duns Number:134614411
Device Description: Sterile endocavity needle guide for use with ECM E610R, Samsung Medison EVN4-9, ER4-9/10ED Sterile endocavity needle guide for use with ECM E610R, Samsung Medison EVN4-9, ER4-9/10ED, EV4-9/10ED and Ultrasonix EC9-5 transducers
Catalog Number
610-987
Brand Name
Needle Guide
Version/Model Number
610-987
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
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
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
abccb340-4bf3-468a-ae75-fe7e877c8f9c
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104708
Quantity per Package
24
Contains DI Package
10841436104705
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 |