Duns Number:003687733
Device Description: Shoe Cover, SureGrip, Anti-Skid, Serged Seams, Blue, XL.
Catalog Number
SH-X1223-NBPK
Brand Name
Critical Cover
Version/Model Number
SH-X1223-NBPK
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)
-
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
0bb56049-06ae-453e-b960-0944161a9f41
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
July 16, 2018
Package DI Number
20817583021100
Quantity per Package
300
Contains DI Package
00817583021106
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |