Duns Number:006999858
Device Description: ComPel Surgical Gown, 2-Ply Front Beryl Green ComPel I, 2-Ply Beryl GreenComPel I Sleeves, ComPel Surgical Gown, 2-Ply Front Beryl Green ComPel I, 2-Ply Beryl GreenComPel I Sleeves, Comfort Panel Back Panels with Carbon, Color Coded ComPel Neck Binding, Tape Tie Closures at Neck and Waist, QCM, Size Large
Catalog Number
75614305
Brand Name
ComPel Surgical Gown
Version/Model Number
75614305
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
f28001c9-aca9-4592-9491-8c3d18dc75cc
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 |