Duns Number:006999858
Device Description: ComPel Surg Gown 2-Ply Front/Sleeves of Beryl Green ComPel, 1-Ply Comfort Panel Back with ComPel Surg Gown 2-Ply Front/Sleeves of Beryl Green ComPel, 1-Ply Comfort Panel Back with Negastat, Color Coded ComPel Neck Binding, Tie Closure at Neck, Circumferentially Offset Sleeves, Overcast Safety Stitch Body, Large
Catalog Number
75612345
Brand Name
ComPel Surgical Gown
Version/Model Number
75612345
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
94be7ac9-d96c-4139-9d21-c35775a56a42
Public Version Date
November 08, 2021
Public Version Number
4
DI Record Publish Date
April 03, 2020
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 |