Duns Number:859290897
Device Description: DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The devi
Catalog Number
D-2001
Brand Name
DiLumen C2
Version/Model Number
DiLumen C2 130 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
K173317,K173317
Product Code
FDF
Product Code Name
Colonoscope And Accessories, Flexible/Rigid
Public Device Record Key
b1b78bba-f4a3-43a9-b037-3fc5e3ca67c8
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 14, 2018
Package DI Number
10858836007024
Quantity per Package
5
Contains DI Package
00858836007027
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 |