mytaMed - mytaView Leak Tester - Mytamed, Inc.

Duns Number:015903922

Device Description: mytaView Leak Tester

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More Product Details

Catalog Number

mV-89544069

Brand Name

mytaMed

Version/Model Number

mV-89544069

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

-

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

FFY

Product Code Name

Adaptor, Bulbs, Miscellaneous, For Endoscope

Device Record Status

Public Device Record Key

22b6c107-b94e-49a3-ab67-20284b508aef

Public Version Date

August 09, 2021

Public Version Number

4

DI Record Publish Date

February 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MYTAMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 861
2 A medical device with a moderate to high risk that requires special controls. 21