Duns Number:079374086
Device Description: Surgical Overlay (26x24") - CE
Catalog Number
-
Brand Name
DabirAir Micropressure
Version/Model Number
DA-102624-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 13, 2016
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
FNM
Product Code Name
Mattress, Air Flotation, Alternating Pressure
Public Device Record Key
1b9199ed-17fa-4b44-98fe-a7d67b9e2612
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 12, 2016
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. | 104 |