Catalog Number

RAR 2011

Brand Name

A.M.I. Recto Anal Repair Probe

Version/Model Number

RAR 2011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 13, 2020

Issuing Agency

In HIBCC

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

K061831,K061831

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

dc638737-391e-4251-a880-9bf75757a00a

Public Version Date

October 04, 2022

Public Version Number

3

DI Record Publish Date

November 28, 2018

Package DI Number

EAMIRAR20111

Quantity per Package

5

Contains DI Package

EAMIRAR20110

Package Discontinue Date

June 13, 2020

Package Status

Not in Commercial Distribution

Package Type

-