Duns Number:160990313
Device Description: MoonPants ML single-use non-sterile garment
Catalog Number
GIS-7ML
Brand Name
MoonPants ML
Version/Model Number
GIS-7-ML
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"
Yes
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
FME
Product Code Name
Gown, Examination
Public Device Record Key
4b5ae162-3fc3-48b7-acab-8f806484fd89
Public Version Date
July 28, 2021
Public Version Number
1
DI Record Publish Date
July 20, 2021
Package DI Number
10893029002608
Quantity per Package
50
Contains DI Package
00893029002601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |