EZX - IMEDICOM CO., LTD.

Duns Number:690340653

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

EZX

Version/Model Number

XST2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Device Record Status

Public Device Record Key

c013ecc1-2234-4c57-a23f-bfb367304106

Public Version Date

February 12, 2020

Public Version Number

3

DI Record Publish Date

August 03, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMEDICOM CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2527
2 A medical device with a moderate to high risk that requires special controls. 59