Duns Number:067486548
Device Description: UltraPhonic Focus Conforming Gel Pad, 2.5 cm x 9 cm
Catalog Number
36-1300-25
Brand Name
Pharmaceutical Innovations
Version/Model Number
UltraPhonic Focus Gel Pad
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MUI
Product Code Name
Media,Coupling,Ultrasound
Public Device Record Key
fe76a0b8-2127-4fb4-87da-a01f240b79bc
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
10300361300250
Quantity per Package
5
Contains DI Package
00300361300253
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |