Duns Number:965417181
Device Description: Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi EUP-V33, EUP-V33W, EUP Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi EUP-V33, EUP-V33W, EUP-V53W, EUP-V12, EUP-CC31, EUP-CC531, EZU-PA5V, C41V, CC41R & CC41R1, and Sonoscape 6V3 (2015 Model & Older) Ultrasound Transducers
Catalog Number
5388
Brand Name
Sterile Disposable Endocavity Needle Guide Kit
Version/Model Number
5388
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
K970893,K971115,K971722,K970893,K971115,K971722
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
6191ed2c-11aa-480a-9d83-46e48f84b1eb
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
March 13, 2020
Package DI Number
10841912106469
Quantity per Package
24
Contains DI Package
00841912106462
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 451 |