Duns Number:025460908
Device Description: GEL,ULTRASOUND,5 LITER JUG
Catalog Number
MDS092010
Brand Name
Medline
Version/Model Number
MDS092010
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)
Yes
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
efd00785-50d7-48ae-9653-a279334dbb2d
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 27, 2016
Package DI Number
40080196166290
Quantity per Package
4
Contains DI Package
10080196166299
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |