Duns Number:200149883
Device Description: Wavelength Ultrasound Gel Clear 250mL
Catalog Number
-
Brand Name
Wavelength
Version/Model Number
NTPC202T
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012522,K012522
Product Code
MUI
Product Code Name
Media, Coupling, Ultrasound
Public Device Record Key
6dd8ae6f-bbcc-4f76-9809-212f5025bec6
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
January 30, 2018
Package DI Number
10628108100193
Quantity per Package
24
Contains DI Package
00628108100196
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |