HDMD PRO - HDMD PRO - MED X CHANGE, INC.

Duns Number:051244569

Device Description: HDMD PRO

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More Product Details

Catalog Number

-

Brand Name

HDMD PRO

Version/Model Number

HDMD PRO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2019

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LMB

Product Code Name

Device, Digital Image Storage, Radiological

Device Record Status

Public Device Record Key

6d067e62-80fd-4611-b584-b57820ac0a40

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

January 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MED X CHANGE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 86