Duns Number:250896255
Device Description: The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consist The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion guide rings, a water inflow tube and a waste hose.
Catalog Number
8143
Brand Name
Pro-Fit
Version/Model Number
Regular Kit with guide rings
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
-
Product Code
FFQ
Product Code Name
Speculum, Rectal
Public Device Record Key
70b0e363-e1df-49df-aa53-32936de167bc
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
07540198001159
Quantity per Package
25
Contains DI Package
07540198001029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispensing Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |