Duns Number:602736795
Device Description: DeClogger Starter Pack
Catalog Number
10935
Brand Name
BIONIX DEVELOPMENT CORPORATION
Version/Model Number
DG-10935
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"
Yes
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
K905164
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
efa1193e-39c4-44a5-b246-e5d1d94c9b42
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 07, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |