Duns Number:783518983
Device Description: SAPS LifeStyle Comfort Surgical Stocking (10-20mmHg) Size: MEDIUM
Catalog Number
-
Brand Name
SAPS LifeStyle Comfort Surgical Stocking (10-20) MEDIUM
Version/Model Number
1020M
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
ITW
Product Code Name
Joint, Ankle, External Brace
Public Device Record Key
2fe09383-1272-4406-9392-4368c0b5659b
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 2020
Package DI Number
10891237001932
Quantity per Package
50
Contains DI Package
00891237001935
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 24 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |
U | Unclassified | 11 |