Catalog Number

A8007-HT-XL

Brand Name

AMD-RITMED

Version/Model Number

A8007-HT-XL

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

FXP

Product Code Name

COVER, SHOE, OPERATING-ROOM

Public Device Record Key

ed4bcce1-c535-422e-b8ef-c9ce1017579c

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

January 16, 2019

Package DI Number

20686864052276

Quantity per Package

3

Contains DI Package

10686864052279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case