Duns Number:658318113
Device Description: Copioumed Surgical Hood helps protect the healthcare facility from microorganism-related c Copioumed Surgical Hood helps protect the healthcare facility from microorganism-related cross-contamination. Surgical hoods provide the most coverage of all products in our headwear range for worry-free performance during surgery.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
SCN0B301-1
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
FYF
Product Code Name
Cap, Surgical
Public Device Record Key
6ea57af2-155e-431c-aab3-92c69584f9a7
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
14719882250498
Quantity per Package
5
Contains DI Package
04719882250491
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 |