Duns Number:658318113
Device Description: Copioumed’s Lab Coat designed to protect health professionals and patients for cross conta Copioumed’s Lab Coat designed to protect health professionals and patients for cross contamination. Single use. Latex free. Coat made of non-woven material with knitted collar and cuffs.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
LCN0B101-1
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
FME
Product Code Name
Gown, Examination
Public Device Record Key
116843dc-319c-47c5-81a8-522169355708
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
14719882250641
Quantity per Package
5
Contains DI Package
04719882250644
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 |