Duns Number:096372255
Device Description: Midmark 6215 AdapterLight Handle Cover With Flange
Catalog Number
-
Brand Name
DeRoyal
Version/Model Number
CH3-F
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
756e7f32-2b31-40f7-9d9c-41c2d0a7c862
Public Version Date
August 27, 2018
Public Version Number
1
DI Record Publish Date
July 25, 2018
Package DI Number
50749756955381
Quantity per Package
1
Contains DI Package
00749756955386
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 | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |