EasyTouch - ET 25G 1 in 1mL Fluringe (FlipLock Exch Needle) - MHC MEDICAL PRODUCTS, LLC

Duns Number:169895245

Device Description: ET 25G 1 in 1mL Fluringe (FlipLock Exch Needle)

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More Product Details

Catalog Number

-

Brand Name

EasyTouch

Version/Model Number

822511

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"

Yes

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

7465c420-1d2e-4853-8c5e-057ac32227f4

Public Version Date

May 12, 2022

Public Version Number

1

DI Record Publish Date

May 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

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