Duns Number:831375089
Device Description: Ultrasound Gel, Low Viscosity, 250 mL, Non-Sterile
Catalog Number
-
Brand Name
PremierPro
Version/Model Number
3413
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101952,K101952
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
1d304e94-4378-402d-9d04-575b0ca6f72e
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
June 15, 2016
Package DI Number
10818566013658
Quantity per Package
12
Contains DI Package
00818566013651
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |