Pro-Fit - The Pro-Fit Regular Speculum Pack is a package - Prime Pacific Health Innovations Corporation

Duns Number:250896255

Device Description: The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices.

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More Product Details

Catalog Number

8115

Brand Name

Pro-Fit

Version/Model Number

Regular Speculum Pack with stop disc

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FFQ

Product Code Name

Speculum, Rectal

Device Record Status

Public Device Record Key

4e00f720-babb-456d-9c07-e741eeec1113

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIME PACIFIC HEALTH INNOVATIONS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3