Catalog Number

-

Brand Name

Anorectal Manometry Catheter

Version/Model Number

CAT003

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K963064,K963064,K963064

Product Code

FFX

Product Code Name

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Public Device Record Key

a00e5c77-8532-44dd-a1b5-a1e85538aa9a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20627825001070

Quantity per Package

20

Contains DI Package

10627825001073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-