Duns Number:006999858
Device Description: Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, 2XL
Catalog Number
-
Brand Name
ComPel MLR Surgical Gown
Version/Model Number
75674913
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041541,K041541
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
1e4d20df-fe7c-4a31-8b48-faef5033a620
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |