Duns Number:830016148
Device Description: 71068EN FUTURO(TM) ANTI-EMBOLISM STOCKINGS, THIGH, LENGTH, CLOSED TOE, LARGE REGULAR, WHIT 71068EN FUTURO(TM) ANTI-EMBOLISM STOCKINGS, THIGH, LENGTH, CLOSED TOE, LARGE REGULAR, WHITE
Catalog Number
71068EN
Brand Name
FUTURO™
Version/Model Number
71068EN
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
dd6477a9-69d5-4031-906b-94be35dd802d
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
July 21, 2016
Package DI Number
50051131201670
Quantity per Package
6
Contains DI Package
30051131201676
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |