Duns Number:047025993
Device Description: Thigh High Compression Stockings (Beige) (Large)
Catalog Number
-
Brand Name
TruCompress
Version/Model Number
SUP2089BGEL
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWL
Product Code Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Public Device Record Key
f055f3a8-bdb4-49df-9e5f-9ed27d217874
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
10810041987119
Quantity per Package
100
Contains DI Package
00810041987112
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 | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |