ME-CHECK H - ESPANSIONE MARKETING SPA

Duns Number:339474539

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More Product Details

Catalog Number

ME-CHECK H

Brand Name

ME-CHECK H

Version/Model Number

ME-CHECK H

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)

Yes

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

PJZ

Product Code Name

Camera, Ophthalmic, General-Use

Device Record Status

Public Device Record Key

e20af53f-335d-4b13-a324-2263d6b342db

Public Version Date

February 26, 2020

Public Version Number

1

DI Record Publish Date

February 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ESPANSIONE MARKETING SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33