Duns Number:679894738
Device Description: Gown_Set-In sleeve_Standard_X-Large_Extra long_W/ two hand towels_Sterile_32ea/cs
Catalog Number
-
Brand Name
Alleset
Version/Model Number
Model 92-2031-S2
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
K102652,K102652
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
5fd88de3-1884-4e4c-b25e-931fd0e9275d
Public Version Date
December 27, 2021
Public Version Number
2
DI Record Publish Date
April 22, 2021
Package DI Number
26931918173068
Quantity per Package
32
Contains DI Package
16931918173061
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 185 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 295 |