Duns Number:025460908
Device Description: COVER,C-ARM,41X74
Catalog Number
DYNJE4400
Brand Name
Medline
Version/Model Number
DYNJE4400
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
Yes
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
-
Product Code
MMP
Product Code Name
Cover, barrier, protective
Public Device Record Key
7d8e1dd1-c8cd-4605-a5c7-0f8c7bbd2c92
Public Version Date
December 04, 2020
Public Version Number
1
DI Record Publish Date
November 26, 2020
Package DI Number
40080196073192
Quantity per Package
20
Contains DI Package
10080196073191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |