Duns Number:929869659
Device Description: One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for c One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Catalog Number
-
Brand Name
LIBBE Colonic Nozzle
Version/Model Number
298-8888
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
-
Product Code
KPL
Product Code Name
Colonic Irrigation System
Public Device Record Key
515c8cb9-faaf-49e6-8c03-dc57ddedaf24
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
April 30, 2021
Package DI Number
10868538000414
Quantity per Package
50
Contains DI Package
00868538000417
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |