Duns Number:034824691
Device Description: T Vacuum Bag for Body Support 138x87cm w/ Klarity Valve25 liter fill with Indexing Bar
Catalog Number
-
Brand Name
Klarity Medical
Version/Model Number
R7221-25BK
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132124
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
694c0a88-586a-4d8d-b8ee-ec16d4410df6
Public Version Date
September 16, 2020
Public Version Number
4
DI Record Publish Date
November 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 483 |