Duns Number:859290897
Device Description: DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The devic DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area.
Catalog Number
D-1000
Brand Name
DiLumen Endolumenal Interventional Platform
Version/Model Number
DiLumen
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"
-
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
K162428,K162428
Product Code
FDF
Product Code Name
Colonoscope And Accessories, Flexible/Rigid
Public Device Record Key
deb00713-347d-4063-9b79-8ade63fc7c46
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 13, 2017
Package DI Number
00865309000218
Quantity per Package
5
Contains DI Package
00865309000201
Package Discontinue Date
-
Package Status
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |