Duns Number:488489766
Device Description: The plastic sleeve is used to cover and keep the handle/motor or footswitch clean and allo The plastic sleeve is used to cover and keep the handle/motor or footswitch clean and allows the motor to enter the sterile field.
Catalog Number
80068
Brand Name
Drape, sterile for motor or footswitch (Straub Medical®)
Version/Model Number
Version 1.0
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
ef22f639-44de-4fad-a4c3-3309108dcbfd
Public Version Date
November 11, 2020
Public Version Number
2
DI Record Publish Date
January 31, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |