Duns Number:012430880
Device Description: Ultrasound Gel Clear
Catalog Number
9004353
Brand Name
Henry Schein
Version/Model Number
9004353
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
30698727-0951-48d8-b1ae-d18d38d6e766
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10304040004064
Quantity per Package
2
Contains DI Package
00304040004067
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 |