Catalog Number

-

Brand Name

AnyCheck

Version/Model Number

IMT-100

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180953,K180953

Product Code

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Public Device Record Key

afa48239-b7b3-4b2b-8ec1-d86746f6ab98

Public Version Date

July 30, 2020

Public Version Number

2

DI Record Publish Date

June 17, 2020

Package DI Number

18800038700007

Quantity per Package

12

Contains DI Package

08800038700000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-