Duns Number:012430880
Device Description: Ultrasound Gel Blue
Catalog Number
9004094
Brand Name
Henry Schein
Version/Model Number
9004094
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
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
b776e922-32ea-428b-92a8-f6530faeddaf
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10304040004071
Quantity per Package
12
Contains DI Package
00304040004074
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |