Duns Number:658318113
Device Description: Copioumed’s Spunbond Shoe Covers offer a protective covering for shoes worn in the healthc Copioumed’s Spunbond Shoe Covers offer a protective covering for shoes worn in the healthcare facility. They help minimize contamination and prevent the transmission of microorganisms between staff and patients and hospital-acquired complications.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
SHN0B101-1
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWP
Product Code Name
Shoe And Shoe Cover, Conductive
Public Device Record Key
7b325834-bdeb-4c67-8cee-c4f55b75fd6e
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
14719882250627
Quantity per Package
20
Contains DI Package
04719882250620
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |