GelPOINT® Path Transanal Access Platform - Transanal Access Platform - APPLIED MEDICAL RESOURCES CORPORATION

Duns Number:187129135

Device Description: Transanal Access Platform

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More Product Details

Catalog Number

-

Brand Name

GelPOINT® Path Transanal Access Platform

Version/Model Number

CNO11

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"

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 Details

Product Code

FER

Product Code Name

Anoscope And Accessories

Device Record Status

Public Device Record Key

1fb5cfe6-203b-4029-ba92-a82a8778b091

Public Version Date

October 30, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10607915134447

Quantity per Package

1

Contains DI Package

00607915134440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"APPLIED MEDICAL RESOURCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 499
2 A medical device with a moderate to high risk that requires special controls. 698
3 A medical device with high risk that requires premarket approval 1