Catalog Number

-

Brand Name

8 Ch. Single Use Anorectal Manometry Catheter

Version/Model Number

9012P1422

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

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

a91a4a67-fe27-4dfe-841d-04d1128812bb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

30627825006980

Quantity per Package

20

Contains DI Package

20627825006983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-