Duns Number:013112308
Device Description: SHOE COVERS 17 X 41 CM, NON-SKID, EA. 100/BOX
Catalog Number
SC01
Brand Name
Rospital Productos Medicos
Version/Model Number
SC01
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)
Yes
Over the Counter (OTC)
-
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
21ee95a4-7935-4f58-b494-996afce27f45
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 29, 2020
Package DI Number
30812460028248
Quantity per Package
10
Contains DI Package
00812460028247
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |