Duns Number:965417181
Device Description: Stainless Steel Reusable Endocavity Needle Guide for Toshiba PVG-600S Ultrasound Transduce Stainless Steel Reusable Endocavity Needle Guide for Toshiba PVG-600S Ultrasound Transducers
Catalog Number
-
Brand Name
Reusable Stainless Steel Endocavity Needle Guide
Version/Model Number
6532
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
K971115,K971722,K971115,K971722
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
4b0f1df6-408a-43e0-af9d-f8565b59841b
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
10841912103147
Quantity per Package
1
Contains DI Package
00841912103140
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 |