Duns Number:130598584
Device Description: BladderScan® Prime Plus™ Probe
Catalog Number
0570-0395
Brand Name
BladderScan®
Version/Model Number
Prime Plus™
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
K153101,K153101,K153101
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
0ba62d95-f5c2-4941-963c-5418ec0729c3
Public Version Date
September 04, 2019
Public Version Number
1
DI Record Publish Date
August 27, 2019
Package DI Number
10879123006490
Quantity per Package
1
Contains DI Package
00879123006493
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 51 |