Catalog Number

A9005

Brand Name

AMD-RITMED

Version/Model Number

A9005

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYF

Product Code Name

CAP, SURGICAL

Public Device Record Key

5655de64-c041-4e5a-a362-5193705b6df8

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 13, 2019

Package DI Number

20686864052597

Quantity per Package

3

Contains DI Package

10686864052590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case