Duns Number:688817949
Device Description: SOFT BOOT SLEEVE Medium 2ea, [One polybag]
Catalog Number
-
Brand Name
DVT-SERIES
Version/Model Number
DS241
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
-
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
K203016,K203417,K203016,K203417,K203016,K203417,K203016,K203417
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
fad41c96-9fb3-475c-8b87-f368984440a1
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 2021
Package DI Number
18809315675694
Quantity per Package
10
Contains DI Package
08809315675697
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 | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 175 |