Duns Number:588625921
Device Description: Disposable surgical gown with adjustable sleeves and cuffs, and chest gusset
Catalog Number
-
Brand Name
SOLOMED Disposable Surgical Gown
Version/Model Number
Large Size
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
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
95d93a5c-33a1-48e2-9183-8478caa30823
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 17, 2020
Package DI Number
17502286510056
Quantity per Package
100
Contains DI Package
07502286510059
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |