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-1002
Brand Name
DiLumen Endolumenal Interventional Platform, 103 cm
Version/Model Number
DiLumen, 103 cm
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
K182540,K182540
Product Code
FDF
Product Code Name
Colonoscope And Accessories, Flexible/Rigid
Public Device Record Key
38ba1a0d-f30f-428a-9b82-8beab5c67d19
Public Version Date
January 21, 2019
Public Version Number
1
DI Record Publish Date
December 19, 2018
Package DI Number
10865309000239
Quantity per Package
5
Contains DI Package
00865309000232
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 |