Duns Number:658318113
Device Description: Copioumed Bouffant Cap provides an ideal headwear for a higher level of protection and com Copioumed Bouffant Cap provides an ideal headwear for a higher level of protection and comfort. The single-use cap features a latex-free elastic band around its circumference. This helps prevent allergic reactions that are due to exposure to latex . Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
SCN0B101-1
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
d5437b93-32b7-4fd5-b1fe-3878c880ca37
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
14719882250412
Quantity per Package
4
Contains DI Package
04719882250415
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 |