Duns Number:256880576
Device Description: Medicom SafeBasics - Shoe Covers Non-Conductive Non-Skid - Blue - X-Large
Catalog Number
8006XL
Brand Name
Medicom SafeBasics
Version/Model Number
8006XL
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
FXP
Product Code Name
COVER, SHOE, OPERATING-ROOM
Public Device Record Key
243e0e8a-b0d7-49c9-a486-0e0c51eb3c12
Public Version Date
January 10, 2022
Public Version Number
3
DI Record Publish Date
January 16, 2019
Package DI Number
20686864049429
Quantity per Package
3
Contains DI Package
10686864049422
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 84 |
2 | A medical device with a moderate to high risk that requires special controls. | 27 |
U | Unclassified | 2 |