EasyTouch - MHC MEDICAL PRODUCTS, LLC

Duns Number:169895245

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More Product Details

Catalog Number

-

Brand Name

EasyTouch

Version/Model Number

627555

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

2c906d62-0e5d-48c3-a4e2-4c1f8576a1ef

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 10, 2016

Additional Identifiers

Package DI Number

MHC16275552

Quantity per Package

100

Contains DI Package

MHC16275551

Package Discontinue Date

-

Package Status

-

Package Type

-

"MHC MEDICAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 184