Catalog Number

MG168R

Brand Name

AESCULAP

Version/Model Number

MG168R

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"

-

For Single-Use

-

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

EXX

Product Code Name

PROBE, RECTAL, NON-POWERED

Public Device Record Key

135f2891-98b8-45b5-ba5b-089b6d09c5f2

Public Version Date

July 29, 2021

Public Version Number

2

DI Record Publish Date

August 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-