Duns Number:965417181
Catalog Number
5404SNR
Brand Name
ProV-Access Vascular Access Needle Guide
Version/Model Number
5404
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
K973958,K973958
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
88bd899e-f807-4f96-89d1-6c7bfbc65744
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
April 27, 2018
Package DI Number
10841912105547
Quantity per Package
10
Contains DI Package
00841912105540
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 |