Duns Number:003375805
Device Description: ESSENTIAL CARE SMALL-SHORT KNE
Catalog Number
-
Brand Name
Albahealth
Version/Model Number
000951012100304
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
f1cc93be-126c-4207-8f93-43ac019925dd
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50073614786795
Quantity per Package
12
Contains DI Package
00073614786790
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 300 |