Duns Number:392994778
Device Description: Neohelp Medium - 38x44cm
Catalog Number
00370915
Brand Name
VYGON
Version/Model Number
37.09.15
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KME
Product Code Name
BEDDING, DISPOSABLE, MEDICAL
Public Device Record Key
7b3e6ddf-66ba-4fd1-a174-3a3de8877b4f
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 2021
Package DI Number
53660812088744
Quantity per Package
4
Contains DI Package
33660812088740
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 | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 195 |