Catalog Number

AM100

Brand Name

ARMEDICA

Version/Model Number

AM100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

INQ

Product Code Name

Table, Powered

Public Device Record Key

caf4b4c6-00a4-464c-b710-fd848721b235

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

B866PAM1001

Quantity per Package

1

Contains DI Package

B866MAM1001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SKID