Duns Number:480870674
Device Description: debritom+ handpiece standard jet
Catalog Number
-
Brand Name
debritom+
Version/Model Number
2000.0003
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2021
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
Yes
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
-
Product Code
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
f5009345-034e-468d-a098-b21ee378a366
Public Version Date
March 31, 2021
Public Version Number
4
DI Record Publish Date
April 02, 2019
Package DI Number
B724200000031
Quantity per Package
5
Contains DI Package
B724200000030
Package Discontinue Date
March 31, 2021
Package Status
Not 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. | 13 |