Duns Number:250896255
Device Description: The Pro-Fit Regular Speculum Pack is a package containing 10 individual Disposable, Single The Pro-Fit Regular Speculum Pack is a package containing 10 individual Disposable, Single-use Speculums with insertion guide rings to be used with compatible Colon Hydrotherapy Devices.
Catalog Number
8142
Brand Name
Pro-Fit
Version/Model Number
Regular Speculum Pack 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
a14e432a-b1a7-4a71-a300-c7f66637f006
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |