Duns Number:102354446
Device Description: Midway Select Explorer DG16 Double End Standard Round Handle
Catalog Number
-
Brand Name
Midway Select
Version/Model Number
002-0653
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
-
Product Code
EKB
Product Code Name
Explorer, Operative
Public Device Record Key
4b6381b3-1de0-4d62-814b-b24ee261365f
Public Version Date
March 23, 2022
Public Version Number
1
DI Record Publish Date
March 15, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 183 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |