Duns Number:333710619
Device Description: This is a medical device.This is a medical device.
Catalog Number
NA
Brand Name
RONDOflex powder 27m (75g)
Version/Model Number
1.000.5955
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042872
Product Code
KOJ
Product Code Name
AIRBRUSH
Public Device Record Key
14ebc469-13f0-4d77-b52b-e9a8d1f2ce4d
Public Version Date
November 08, 2021
Public Version Number
5
DI Record Publish Date
September 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 153 |