Duns Number:131500998
Device Description: Delf1 Irrigation Tubing 1-Way Single Use (10 Pack)
Catalog Number
DELF1-07
Brand Name
Delfin1
Version/Model Number
DELF1-07
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
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
EBW
Product Code Name
Controller, Foot, Handpiece And Cord
Public Device Record Key
4b4b0737-7a67-466c-96f2-21ee3fd675e4
Public Version Date
July 02, 2019
Public Version Number
1
DI Record Publish Date
June 24, 2019
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 | 329 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 918 |