Duns Number:602736795
Device Description: DeClogger 14-16 F/Blue
Catalog Number
911
Brand Name
BIONIX DEVELOPMENT CORPORATION
Version/Model Number
DG-911
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2017
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K905164,K905164
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
86a170c2-ebd5-4d0d-a205-47cc4f4750d8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 2016
Package DI Number
08599110040010
Quantity per Package
10
Contains DI Package
08599110040065
Package Discontinue Date
February 01, 2017
Package Status
Not in Commercial Distribution
Package Type
box
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 |