Duns Number:658318113
Device Description: Copioumed’s scrub suits are protective outfits made for medical personnel for use in opera Copioumed’s scrub suits are protective outfits made for medical personnel for use in operating rooms when they might come in touch with an infectious substance or body fluid.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
SSN0B101-1
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
FXO
Product Code Name
Suit, Surgical
Public Device Record Key
f5d81fc9-9d6c-43aa-afc7-56826a9faabf
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
14719882250801
Quantity per Package
5
Contains DI Package
04719882250804
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 |