Duns Number:063519193
Device Description: DePuy Mitek Foot Switch Covers Clear Polyethylene 24in x 24in x 1in 100 per Case
Catalog Number
284156
Brand Name
DePuy Mitek
Version/Model Number
24701
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 29, 2019
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
95c621b5-ff7b-4f17-a637-5d69bfd696ae
Public Version Date
October 01, 2020
Public Version Number
7
DI Record Publish Date
October 12, 2016
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |