Duns Number:006999858
Device Description: OR GWN COMPEL NEGA KAUM BL 2XL - RM (98 8305) USE: 75656693
Catalog Number
7565V493
Brand Name
ComPel Surgical Gown
Version/Model Number
7565V493
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
K041539,K041539
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
aee28a57-75ca-4817-881e-de98445191fc
Public Version Date
November 08, 2021
Public Version Number
7
DI Record Publish Date
January 29, 2018
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 |