Duns Number:686206765
Device Description: Gown No Reinforced
Catalog Number
100780
Brand Name
CustoMed
Version/Model Number
1
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
aef40459-f15a-4217-b318-b90690a94bce
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
July 16, 2020
Package DI Number
84895237141198
Quantity per Package
30
Contains DI Package
04895237141192
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |